Method for operating a sorter device in an IVD laboratory system and IVD laboratory system

Abstract

The present disclosure relates to a method for operating a sorter device (5) in an IVD laboratory system. The method includes providing a sorter device (5) in an IVD laboratory system (1) provided with a system operation controller (3). The sorter device (5) includes a plurality of sample container racks each provided with a receiving hole for receiving a sample container (4), a handling device configured to pick up the sample container (4) from the receiving hole of the sample container rack and place the sample container (4) in the receiving hole of the sample container rack, a sorter device controller configured to control the operation of the sorter device (5) and connectable to the system operation controller (3), and an output device functionally connected to the sorter device controller and configured to output at least one of audio data and video data. The sorter device (5) is configured in a pre-operation process, and the configuration includes assigning a plurality of sample container racks to a plurality of processing sub-targets executed by the IVD laboratory system (1) during operation, assigning a first sample container rack to a first processing sub-target, and assigning a second sample container rack to a second processing sub-target different from the first processing sub-target; and assigning a first threshold to the first sample container rack, the first threshold being the first threshold number of sample containers (4) in the first sample container rack and being smaller than the maximum number of sample containers (4) that can be received in the first sample container rack. The sorter device (5) operates in an operation process, and the operation includes placing the sample container (4) in the receiving hole of the first sample container rack by the handling device, determining, by the sorter device controller, a first current number of sample containers (4) received in the first sample container rack, comparing, by the sorter device controller, the first current number of sample containers (4) with the first threshold, and outputting first warning data via the output device when the first current number of sample containers (4) is the same as or greater than the first threshold. Further, an IVD laboratory system (1) is provided.

Description

Technical Field

[0001] The present disclosure relates to a method for operating a sorter device in an IVD laboratory system and an IVD laboratory system.

Background Art

[0002] An in-vitro-diagnostics (IVD) laboratory system is applied to test / analyze samples such as blood or tissue samples taken from a human body, such as samples of body fluids, in particular essentially automatically. In-vitro diagnostics can detect diseases and other conditions and can be used to monitor a person's overall health status to aid in the treatment, management, or prevention of diseases. Furthermore, an IVD laboratory system can also be applied to precision medicine to identify patients who are likely to benefit from a particular treatment or therapy. In-vitro diagnostic tests performed by an IVD laboratory system are typically used in a laboratory or other healthcare professional environment.

[0003] Such an IVD laboratory system can include a plurality of IVD devices. The IVD devices can be provided with a plurality of IVD components or modules (e.g., devices or instruments). The IVD devices can be, for example, pre-analytical, analytical, and / or post-analytical IVD devices. In an IVD laboratory system, sample containers typically move along a processing line for processing. For example, an IVD sample container can be moved or repositioned from a first IVD device provided on a processing line within the IVD laboratory system to a second IVD device. The IVD devices can provide IVD workstations or locations.

[0004] U.S. Patent No. 9,753,048 relates to a sample test automation system. In the sample test automation system, a sample tray on which a plurality of samples can be placed is provided, an identifier for discriminating the sample tray is attached to the sample tray, an identifier reading device for reading the identifier of the sample tray is provided at the sample introduction section, and information regarding the sample is switched based on the read identifier of the sample tray.

[0005] U.S. Patent Application Publication No. 2014 / 0294699 discloses a specimen transfer device capable of transferring a specimen between carriers for different types of conveyance. A plurality of trays capable of holding a specimen carrier at the transfer destination are provided, and these trays can be freely grouped.

[0006] U.S. Patent No. 6,255,614 relates to an apparatus including a conveyor unit for conveying a specimen container rack, a specimen container ID reading section for reading a specimen container identification number of the specimen container rack conveyed by the conveyor unit, a specimen container storage rack table for installing a specimen container storage rack for accommodating the specimen container, a specimen container transfer mechanism for taking out the specimen container from the specimen container rack and putting it into the specimen container storage rack, and a control unit for controlling the order of putting the specimen container into the specimen container storage rack.

SUMMARY OF THE INVENTION

[0007] An object of the present disclosure is to provide a method for operating a sorter device in an IVD laboratory system and an IVD laboratory system, which are improved methods and an IVD laboratory system that reduce the risk of interruption of the operation of the IVD laboratory system.

[0008] To solve this problem, there is provided a method according to claim 1 for operating a sorter device in an IVD laboratory system. Further, an IVD laboratory according to claim 15 is provided. Further embodiments are disclosed in the dependent claims.

[0009] According to one aspect, a method for operating a sorter device in an IVD testing laboratory system is provided. The method includes providing a sorter device in an IVD testing laboratory system provided with a system operation controller. The sorter device includes a plurality of sample container racks each provided with a receiving hole for receiving a sample container, a handling device configured to pick up a sample container from the receiving hole of the sample container rack and place the sample container in the receiving hole of the sample container rack, a sorter device controller configured to control the operation of the sorter device and connectable to the system operation controller, and an output device functionally connected to the sorter device controller and configured to output at least one of audio data and video data. In a pre-operation process, configuring the sorter device includes assigning a plurality of sample container racks to a plurality of processing subtargets executed by the IVD testing laboratory system during operation, assigning a first sample container rack to a first processing subtarget, and assigning a second sample container rack to a second processing subtarget different from the first processing target; and assigning a first threshold to the first sample container rack, the first threshold being the first threshold number of sample containers in the first sample container rack and being smaller than the maximum number of sample containers that can be received by the first sample container rack. In an operation process, operating the sorter device includes placing a sample container in the receiving hole of the first sample container rack by the handling device, determining, by the sorter device controller, a first current number of sample containers received in the first sample container rack, comparing, by the sorter device controller, the first current number of sample containers with the first threshold, and outputting, via the output device, first warning data when the first current number of sample containers is the same as or greater than the first threshold.

[0010] According to another aspect, an IVD examination room system is provided that includes a system operation controller and a sorter device. The sorter device includes a plurality of sample container racks each provided with a receiving hole for receiving a sample container, a handling device configured to pick up a sample container from the receiving hole of the sample container rack and place the sample container in the receiving hole of the sample container rack, a sorter device controller configured to control the operation of the sorter device and connectable to the system operation controller, and an output device functionally connected to the sorter device controller and configured to output at least one of audio data and video data. The IVD examination room system is configured to operate, including configuring the sorter device in a pre-operation process. Configuring the sorter device includes assigning a plurality of sample container racks to a plurality of processing subtargets to be executed by the IVD examination room system during operation, assigning a first sample container rack to a first processing subtarget, and assigning a second sample container rack to a second processing subtarget different from the first processing target; and assigning a first threshold value representing a first threshold number of sample containers for receiving sample containers in the first sample container rack to the first sample container rack. Further, there is an operation process of operating the sorter device. Operating the sorter device includes placing a sample container in the receiving hole of the first sample container rack by the handling device, determining a first current number of sample containers received in the first sample container rack by the sorter device controller, comparing the first current number of sample containers with the first threshold value by the sorter device controller, and outputting first warning data via the output device when the first current number of sample containers is the same as or greater than the first threshold value.

[0011] The sorter device can provide storage for a plurality of sample containers that are processed, for example, by one of the IVD devices in an IVD examination room system, or are processed for sorting or long-term storage. One or more sorter devices may be provided in the IVD examination room system. When a plurality of sorter devices are provided in the IVD examination room system, the sorter devices may be arranged at different positions in the IVD examination room system. For example, a sorter device may be provided for introducing sample containers into the workflow of the IVD examination room system. Similarly, the sorter device can function for storing sample containers that exit some workflow within the IVD examination room system.

[0012] During the operation of the sorter device, it is checked whether the number of sample containers currently received in the first sample container rack is less than or equal to a first threshold value. For example, the first threshold value may indicate a value of 70% to 90% of the maximum number of sample containers that can be received in the first sample container rack. Therefore, before the current number of sample containers received in the first sample container rack approaches or reaches the maximum number of sample containers that can be received in the receiving holes of the first sample container rack, warning data (warning information, warning signal) is output via the output device, informing the operator of the IVD examination room system that there is a possibility that the first sample container rack will be completely full of sample containers in the near future. In response to this, the operator can start the steps or measures necessary to avoid a complete fullness of the first sample container rack. Such a complete fullness, that is, all the receiving holes of the first sample container rack receiving sample containers, may interrupt further operation or workflow of the IVD examination room system.

[0013] The first threshold is set in a pre - operation process that is performed prior to the actual operation of the sorter device, and such an operation is part of the operation of the IVD test laboratory system. The pre - operation process can be performed, for example, in the design process when installing the IVD test laboratory system. Also, the pre - operation process can be performed at the time of restart after some non - operating time of the IVD test laboratory system.

[0014] This method may further include assigning a second threshold representing the second threshold number of sample containers in the second sample container rack to the second sample container rack, where the second threshold number of sample containers is less than the maximum number of sample containers that can be received by the second sample container rack, and the second threshold is different from the first threshold. The operation of the sorter device in the operation process includes placing a sample container in the receiving hole of the second sample container rack by the handling device, determining the second current number of sample containers received in the second sample container rack by the sorter device controller, comparing the second current number of sample containers with the second threshold by the sorter device controller, and outputting second warning data via the output device when the second current number of sample containers is the same as or greater than the second threshold. Thresholds representing the individual threshold numbers of sample containers that can be received by any one of a plurality of sample container racks can be set or configured for one or more of the sample container racks. The thresholds can be set independently for each of the sample container racks. In the operation of the sorter device (of the IVD test laboratory system), the current number of sample containers received in the sample container rack to which the threshold is assigned is determined and compared with the pre - set threshold.

[0015] For one or more of the sample container racks, the determination of the current number of sample containers received in the sample container rack may be determined multiple times during the operation of the IVD testing laboratory system. For example, the determination of the current number of sample containers received in such a sample container rack may be initiated by some specific event and / or may be periodically initiated after the elapse of some predetermined time. For example, the determination of the current number of sample containers may be determined every minute. The first and / or second current numbers of sample containers received in the first / second sample container rack may be continuously determined during the operation or operation of the IVD testing laboratory system.

[0016] The method may comprise at least one of: assigning a plurality of sample container racks to a plurality of processing sub-targets in response to a user input of a rack assignment received at least in one of a sorter device controller and a system operation controller of the IVD testing laboratory system; and assigning a first threshold value to a first sample container rack in response to a user input of a first threshold value received at least in one of a sorter device controller and a system operation controller of the IVD testing laboratory system. The user input of the rack assignment represents an assignment between at least one sample container rack and a processing sub-target assigned to the at least one sample container rack. The user input may be received via a user interface that enables the user to make a selection from among a plurality of processing sub-targets executed in the operation of the IVD testing laboratory system, for example. For the user to make a selection, a menu that enables the user to select a processing sub-target assigned to any of the sample container racks may be displayed on a display device of the user interface.

[0017] The processing sub-targets may, in various embodiments, include one or more of the following processing sub-targets: transporting a sample container between IVD devices, bringing the sample container to a refrigerator, bringing the sample container into a workflow within an IVD laboratory system, bringing the sample container to an IVD analyzer, sorting the sample container, and bringing the sample container to a storage location outside the IVD laboratory system. Sample containers processed according to one and the same processing sub-target can be brought to a sample container rack within the sorter device to which such a processing sub-target is assigned.

[0018] In the operation process, the first threshold may be updated by a modified first threshold representing a modified first threshold number of sample containers, the modified first threshold being different from the first threshold, the current first number of sample containers being compared with the modified first threshold modified by the sorter device controller, and first warning data being output via the output device when the current first number of sample containers is the same as or greater than the modified first threshold. According to such an example, the first threshold set or configured initially can be modified during the operation of the IVD laboratory system. The first threshold may be modified or updated dynamically, thereby adjusting the first threshold as needed. The modified first threshold may be received by user input.

[0019] The second threshold may be updated by a modified second threshold in response to the update of the first threshold. For example, when a second sample container rack is filled with sample containers after the first sample container rack is completely filled, the first and second thresholds may be linked, such that when the modified first threshold assigned due to the update of the first threshold is assigned, the second threshold is updated.

[0020] In the operation process, this method may further include determining an operation parameter representing at least one of the current operation characteristics of the IVD test room system, such as the current operation characteristics of the sorter device and the current operation characteristics of the IVD device provided in the IVD test room system, and determining a first threshold value modified according to the operation parameter. The update of the first threshold value by the modified first threshold value is performed according to the operation parameter, whereby the first threshold value is adjusted according to the actual operation of the IVD test room system. For example, when it is determined that the IVD test room system is switched from the first operation mode to the second operation mode, in response thereto, the first threshold value can be updated by the modified first threshold value. The first and second operation modes may refer to, for example, the IVD test room system performing different workflow designs.

[0021] The operation parameter may represent at least one operation characteristic selected from the sample container processing capacity of the sorter device, the sample container processing capacity of the IVD test room system, the sample container processing capacity of at least one IVD device, the sample container processing capacity of the first processing sub-target, and the sample container processing capacity of the handling device. The processing capacity of the sample container refers to the number of sample containers processed or handled within a certain time period, such as the number of sample containers processed or handled within 5 minutes or 1 hour. Different processing capacity values can be determined based on different time periods applied to determine the processing capacity value. For example, the switching between the first operation mode and the second operation mode of the IVD test room system may result in the application of different determinations of processing capacity, which may cause the update of the first threshold value and / or any other threshold value.

[0022] The first threshold may be updated in response to the output of the first warning data via the output device. In this example, the update of the first threshold by the corrected first threshold is performed in response to the determination of the output of the first warning data. For example, considering the current processing capacity value, the first threshold may be increased, whereby a larger number of sample containers can be received in the first sample container rack before the warning data is output. Such a measure may be executed, for example, when the processing capacity value is considered to be quite low. Thereby, the first threshold can be increased to a higher level.

[0023] For example, the processing capacity can be high due to the handling device or the high-speed gripper, or due to the operating system being supplemented with additional handling devices or grippers. In this case, it is possible to reach the maximum number of sample containers earlier than usual. The threshold can be set to a lower value so that the operator can react without delay after exceeding the threshold and before reaching the maximum number of sample containers. For example, the sample container processing capacity of the sorter device, the IVD inspection room system, any IVD device, the first processing sub-target, and / or the handling device can always be monitored, and the monitored data can be held in one or more operating parameters. If one or more of these operating parameters exceed the average value of the one or more operating parameters by a predetermined amount, the threshold can be set to a lower value. For example, the threshold can be decreased in predetermined increments. This process can be repeated, resulting in a plurality of increments of decrease of the threshold.

[0024] As another example, the processing capacity can be low due to maintenance, or due to problems with the drive motor, or due to general low performance in the operating system or lack of sample containers. In this case, it may take longer than normal to reach the maximum number of sample containers. To avoid unnecessary interactions on behalf of the operator, the threshold can be set to a higher value. Similar to the previous example, the throughput of the sample containers can be monitored. When the operating parameter falls below the average value of one or more operating parameters by a predetermined amount, the threshold can be set to a larger value. For example, the threshold can be increased in predetermined increments. The increment of the increment may be equal to the decrement of the increment in the above example.

[0025] The method may further include, in the operation process, assigning to a first sample container rack a modified first processing sub-target that is different from the first updated processing sub-target, and updating a first threshold value in response to the assignment of the modified first processing sub-target to the first sample container rack. In this example, since a new or different processing sub-target is assigned to the first sample container rack, the first threshold value is modified or updated. The new or different processing sub-target may imply different needs for the first sample container rack that cause the modification or update of the first threshold value.

[0026] In the pre-operation process, the method may further include generating sorter device configuration data representing the assignment of a plurality of processing sub-targets of a plurality of sample container racks and the assignment of a first threshold to a first sample container rack, storing the sorter device configuration data in a storage device assigned to the IVD laboratory system, retrieving the sorter device configuration data from the storage device, providing the sorter device configuration data to the sorter device, and configuring the sorter device according to the sorter device configuration data. By being stored, the sorter device configuration data becomes available for any additional or subsequent configuration of the sorter device. For example, the sorter device configuration data may be generated and stored in an initial stage of generating the design or layout of the IVD laboratory system. Subsequently, when the IVD laboratory system actually operates for sample handling and processing, the sorter device configuration data can be received and applied to the configuration of the sorter device.

[0027] The sorter device configuration data can be retrieved from the storage device in response to receiving a start request for starting the operation of the sorter device in at least one of the system operation controller and the sorter device controller. For example, in response to a user input and in response to a start request received to start the operation of the sorter device, the sorter device configuration data is provided to configure the sorter device. Such a configuration may be executed at any time during the (re)start of the IVD laboratory system.

[0028] The configuration of the sorter device in the pre-operation process may be performed, at least in part, by a sorter device layout module that can be operably connected to at least one of a system operation controller and a sorter device controller. The sorter device layout module may be provided by a software module operating on one or more processors and is configured to generate sorter device configuration data applied to the configuration of the sorter device. The sorter device layout module may be connected to the system operation controller of the IVD examination room system and may provide the sorter device configuration data to a sorter device such as a sorter device controller. Alternatively, the sorter device layout module may be directly connected to the sorter device controller.

[0029] The sorter device layout module may be provided as a sub-module of the system operation controller.

[0030] The method may further include assigning a first threshold to a subset of the receiving holes of the first sample container rack, the first threshold representing a first threshold number of sample containers within the first sample container rack, and the first threshold number of sample containers being less than the maximum number of sample containers that can be received in the subset of the receiving holes of the first sample container rack. In this example, the first threshold is assigned to a subset of the receiving holes of the first sample container rack rather than the first sample container rack as a whole. Different thresholds may be assigned to further subsets of the receiving holes of the first sample container rack. Different subsets of the receiving holes of the first sample container rack may be assigned to different processing sub-targets. During operation, the full level (the number of sample containers currently received) is determined independently for the subsets of the receiving holes. Warning data can be generated independently for the subsets of the receiving holes as needed.

[0031] Furthermore, the method may further include providing a plurality of sample container racks arranged on a plurality of trays, each configured to receive one or more sample container racks from a plurality of sample container racks. For example, similar to the threshold assigned to a sample container rack, a threshold representing the threshold number of sample containers for receiving sample containers in one or more sample container racks arranged on the tray may be assigned to the tray carrying one or more sample container racks, and the threshold is smaller than the maximum number of sample containers that can be received by the tray. Regarding the generation and output of warning data, the processing and handling of such a threshold assigned to the tray can be performed as described for the threshold assigned to the sample container rack.

[0032] The IVD testing laboratory system is provided with a plurality of sample containers, which may also be referred to as IVD sample containers configured to receive one or more samples processed in the IVD testing laboratory system. The sample containers may be tubes. The sample containers may be received in a sample container rack or pack that provides a sample container holder or carrier. The sample container holder or carrier is configured to receive one or more sample containers. The sample containers may be configured to receive one or more samples processed in the testing laboratory system. The sample containers may be handled or processed only by a subset of the IVD devices of the IVD testing laboratory system or a single IVD device.

[0033] In the sorter device, the sample container can be lifted from the receiving hole of the sample container rack or placed in the receiving hole of the sample container rack.

[0034] Biological samples that can be received in a sample container can include, for example, biological substances collected from the human body or an animal body. Biological samples can include body fluids such as blood, interstitial fluid, urine, saliva, or other types of body fluids. For simplicity, biological samples are typically simply referred to as "samples" herein.

[0035] A sample can potentially contain at least one analyte of interest, such as, for example, molecules, ions, proteins, metabolites, pathogens, etc. Typically, one of the roles of an IVD test is to detect the presence and / or concentration of one or more analytes in a sample. More generally, an IVD test can refer to determining the biological characteristics of a sample. An IVD test can include performing at least one analytical test on a sample, and the analytical test can be capable of drawing conclusions regarding the biological characteristics of the sample. The analytical test can include, for example, the addition of a reagent to the sample, a detectable reaction that may occur between the sample and the reagent, and / or the detection or non-detection of this reaction. The detection of the reaction can include, for example, measuring physical values of the sample (or a complex obtained by using the sample), such as the spectrum and / or intensity of radiation reflected by and / or transmitted through the sample (or the complex obtained by using the sample).

[0036] The processing of samples in an IVD testing laboratory system can include, for example, transporting a sample (typically in a sample container such as a tube, which may be held in a sample container holder such as a tube rack), performing pre - analysis steps on the sample (such as preparation steps like centrifugation), performing analysis steps on the sample (such as adding reagents to the sample and measuring the reaction between the sample and the reagents), and / or performing post - analysis steps on the sample (such as storing the sample in a refrigerator for later use).

[0037] IVD testing laboratory equipment or an IVD testing laboratory system comprises one or more IVD (testing laboratory) devices designed to process samples, such as by performing one or more steps of a workflow intended for the sample. The processing of the sample can include one or more physical processing steps (such as moving, mixing, heating, etc.). The IVD device can include device hardware for processing the sample (such as grippers, reagent storage, pipetting devices, heating elements, etc.), as well as device software designed to operate the device hardware. The IVD testing laboratory equipment can comprise a control unit designed to control, and in particular to operate, the operation of the device hardware, and the device software can be designed to be executed using the control unit.

[0038] IVD laboratory equipment is typically classified according to the various types of sample processing steps it can perform. Transport IVD laboratory equipment is designed, for example, to transport a sample (or a sample container and / or its respective sample container holder) from one IVD laboratory equipment to another IVD laboratory equipment. Pre-analytical IVD laboratory equipment is designed to perform pre-analytical steps on a sample. Analytical IVD laboratory equipment is designed to perform an analytical step (such as an analytical test) on a sample, and the analytical IVD laboratory equipment can include digital analytical IVD laboratory equipment designed to perform an analytical calculation step (such as a medical algorithm). Post-analytical IVD laboratory equipment is designed to perform post-analytical steps on a sample. Some IVD laboratory equipment can perform multiple types of sample processing steps, such as pre-analytical steps and analytical steps, for example.

[0039] In one example, the IVD laboratory equipment includes two pre-analytical IVD laboratory equipment, five analytical IVD laboratory equipment, one post-analytical IVD laboratory equipment, and one transport IVD laboratory equipment, and the IVD laboratory equipment is designed such that one transport IVD laboratory equipment connects all the other IVD laboratory equipment.

[0040] The IVD laboratory system may include a transport system configured to transport sample containers within the IVD laboratory system. The transport system may be configured to transport the sample containers along the flow of the sample containers. The transport may be fully automated or substantially automated. The transport system may be supported by user interaction. The user can transport the sample containers along at least a portion of the flow of the sample containers. This user transport can be part of daily activities. Brief Description of the Drawings

[0041] Description of Further Embodiments Hereinafter, embodiments will be described by way of example with reference to the drawings.

[0042]

Figure 1

Figure 2

Figure 3

Embodiments for Carrying Out the Invention

[0043] FIG. 1 shows a schematic diagram of an element or component of an IVD examination room system 1 including a plurality of IVD devices 2 for providing a workflow for a sample to be analyzed received in a sample container. An operation system controller 3 configured to control and manage the operations of the plurality of IVD devices 2 is provided to perform at least one of pre-analysis, analysis, and post-analysis of a sample such as a blood or tissue sample collected from a human body, such as a sample of body fluid.

[0044] A sample container 4 that receives a sample to be analyzed in the IVD examination room system 1 can be received and stored in a sorter device 5 that can be connected to the workflow between the IVD devices 2 at any location along the workflow. For example, the sample container 4 can be received from the workflow into the sorter device 5. Similarly, the sample container 4 may be provided from the sorter device 5 to the workflow established between the IVD devices 2. One or more sorter devices 5 may be provided in the IVD examination room system 1.

[0045] FIG. 2 shows a schematic diagram of a sorter device 5 provided with a tray 10 carrying a plurality of sample container racks 11a, 11b, and each sample container rack includes a plurality of receiving holes 12 configured to receive one of the sample containers 5 to be processed by the IVD device 2 or the sample containers 5 processed by the IVD device 2.

[0046] According to FIG. 2, the sorter device 5 is provided with a handling device 13 configured to place a sample container in the receiving holes 12 of the sample container racks 11a and 11b and pick up the sample container 4 from the receiving holes 12. In order to perform operations for such picking up and placing, the handling device 13 is movable across the arrangement of the sample container racks 11a and 11b received on the tray 10.

[0047] The operation of the sorter device 5 is controlled by a sorter device controller 14 that can be connected to the operation system controller 3. According to FIG. 2, the sorter device controller 14 is connected to a user interface 15 configured to output output data (such as audio and / or video data) and receive user input from an operator of the IVD examination room system 1.

[0048] Next, with reference to the schematic diagram of FIG. 3, a method for operating the sorter device 5 in the IVD examination room system 1 will be described. In the pre-operation process, a configuration of the sorter device 5 including assigning a plurality of sample container racks 11a and 11b to a plurality of processing sub-targets executed by the IVD examination room system 1 during operation is executed (step 30). A plurality of different processing sub-targets may be executed during the operation of the IVD examination room system 1.

[0049] One of the processing sub-targets is assigned to each of the plurality of sample container racks 11a, 11b. The first processing sub-target is assigned to the first sample container rack 11a. A second processing sub-target different from the first processing sub-target is assigned to the second sample container rack 11b. Based on such an assignment, the various sample container racks 11a, 11b receive and store the sample containers 4 to be processed by the handling device 13 according to the processing sub-targets assigned to the respective sample container racks 11a, 11b. Therefore, in this example, the same processing sub-target is assigned to the sample container rack 11a or 11b and the sample container 4 received in the receiving hole 12 of such a sample container rack 11a or 11b.

[0050] The handling device 13 movable across the area of the tray 10 for receiving the sample container racks 11a, 11b is configured to pick up and place the sample container 4.

[0051] The processing of samples in the IVD examination room system 1 (for example, providing processing sub-targets) can include, for example, transporting the samples (brought to the sample container 4 such as a tube), performing pre-analysis steps (for example, preparation steps such as centrifugation) on the samples, performing analysis steps on the samples (for example, adding reagents to the samples and measuring the reaction between the samples and the reagents), and / or performing post-analysis steps on the samples (for example, storing the samples in a refrigerator for later use).

[0052] The IVD machine 2 is designed to process a sample, such as performing one or more steps of a workflow intended for the sample. The processing of the sample can include one or more physical processing steps (e.g., moving, mixing, heating, etc.). The IVD machine 2 can include device hardware for processing the sample (e.g., grippers, reagent storage, pipetting devices, heating elements, etc.), as well as device software designed to operate the device hardware. The IVD machine 2 can be provided with a control unit designed to control, and in particular to operate, the operation of the device hardware, and the device software can be designed to be executed using the control unit.

[0053] Furthermore, according to step 31, a first threshold representing a first threshold number of sample containers 4 that can be received in the first sample container rack 11a is assigned to the first sample container rack 11a. Such a first threshold number of sample containers 4 is smaller than the maximum number of sample containers 4 that can be received in the first sample container rack 11a. For example, the first threshold number may correspond to 70%, 80%, or 90% of the maximum number of sample containers 4 that can be received in the receiving holes 12 of the first sample container rack 11a.

[0054] Optionally, in step 32, sorter device configuration data can be generated that represents both the assignment of the plurality of processing sub-targets to the plurality of sample container racks 11a, 11b and the assignment of the first threshold to the first sample container rack 11a. Such sorter device configuration data can be stored in a storage device (not shown) assigned to the IVD laboratory system 1. When the sorter device configuration data is generated and stored, in step 33, the sorter device configuration data can optionally be retrieved from the storage device and provided for the configuration of the sorter device 5. For example, the sorter device configuration data can be generated and stored in an initial stage of generating the design or layout of the IVD laboratory system 1. Thereafter, when the IVD laboratory system 1 actually operates for sample handling and processing, the sorter device configuration data can be received and applied to the configuration of the sorter device 5.

[0055] In an operating process for operating the sorter device 5 (while operating or executing the IVD laboratory system 1), the sample container 5 is placed in the receiving hole 12 of the first sample container rack 11a by the handling device 13. During such an operation, in step 34, the first current number of the sample containers 4 currently received in the first sample container rack 11a is determined one or more times by the sorter device controller 14.

[0056] The first current number of such sample containers 4 is compared by the sorter device controller 14 with a first threshold value in step 35. If the first current number of the sample containers 4 is the same as or greater than the first threshold value, first warning data is output via the user interface 15 by outputting at least one of audio data and video data (step 35). The first warning data informs the operator of the IVD test laboratory system 1 that the current number of sample containers 4 received in the first sample container rack 11a has reached the threshold value. This provides the operator with an indication that the first sample container rack 11a is becoming full with sample containers 4. In response, the operator can take the necessary measures to avoid a complete filling of the first sample container rack 11a, which could cause an interruption in the operation of the IVD test laboratory system 1. For example, the operator can allocate another sample container rack to the same sub-target to which the first sample container rack 11a is allocated, thereby providing additional storage capacity for the sample containers 4 in the event that the first sample container rack 11a becomes completely full. The interruption of the operation of the sorter device 5 and the IVD test laboratory system 1 is avoided.

[0057] The method described above for the first sample container rack 11a can be applied to one or more additional sample container racks from the plurality of sample container racks 11a, 11b on the tray 10.

[0058] The threshold value assigned to one of the sample container racks 11a, 11b may be updated or modified during the operation of the sorter device 5 according to several operating characteristics determined for the IVD test laboratory system 1. For example, if it is determined that the IVD test laboratory system 1 has been switched from a first operating mode to a second operating mode, in response, the first threshold value can be updated with a modified first threshold value. The first and second operating modes may refer, for example, to the IVD test laboratory system 1 executing different workflow designs.

Claims

1. A method for operating a sorter device (5) in an IVD test room system, comprising: providing a sorter device (5) in an IVD test room system (1) provided with a system operation controller (3), wherein the sorter device (5) comprises: a plurality of sample container racks (11, 11b) each provided with a receiving hole (12) for receiving a sample container (4); a handling device configured to pick up a sample container (4) from the receiving hole (12) of the sample container rack (11a, 11b) and place the sample container (4) in the receiving hole (12) of the sample container rack (11a, 11b); a sorter device controller (14) configured to control the operation of the sorter device (5) and connectable to the system operation controller (3); an output device (15) functionally connected to the sorter device controller (14) and configured to output at least one of audio data and video data; providing the sorter device (5); configuring the sorter device (5) in a pre-operation process, assigning the plurality of sample container racks (11a, 11b) to a plurality of processing sub-targets executed by the IVD test room system (1) during operation, assigning a first sample container rack (11a) to a first processing sub-target and a second sample container rack (11b) to a second processing sub-target different from the first processing sub-target; assigning a first threshold to the first sample container rack (11a), the first threshold being the first threshold number of sample containers (4) in the first sample container rack (11a) and being smaller than the maximum number of sample containers (4) that can be received by the first sample container rack (11a); configuring the sorter device (5); operating the sorter device (5) in an operation process, placing a sample container (4) in the receiving hole (12) of the first sample container rack (11a) by the handling device (13); Determining a first current number of sample containers (4) received in the first sample container rack (11a) by the sorter device controller (14); Comparing the first current number of the sample containers (4) with the first threshold value by the sorter device controller (14); Outputting first warning data via the output device (15) when the first current number of the sample containers (4) is the same as or greater than the first threshold value; Operating the sorter device (5) including; A method including.

2. Assigning a second threshold value representing a second threshold number of sample containers (4) in the second sample container rack to the second sample container rack (11b); Further including, The second threshold number of the sample containers (4) is smaller than the maximum number of sample containers (4) that can be received in the second sample container rack (11b), The second threshold value is different from the first threshold value, Operating the sorter device (5) in the operation process includes: Placing the sample container (4) in the receiving hole (12) of the second sample container rack (11b) by the handling device; Determining a second current number of sample containers (4) received in the second sample container rack (11b) by the sorter device controller (14); Comparing the second current number of the sample containers (4) with the second threshold value by the sorter device controller (14); Outputting second warning data via the output device when the second current number of the sample containers (4) is the same as or greater than the second threshold value; The method according to claim 1, further including.

3. Assigning the plurality of sample container racks (11a, 11b) to the plurality of processing sub-targets in response to a user input of rack assignment received by at least one of the sorter device controller (14) and the system operation controller (3) of the IVD examination room system (1), and In response to a user input of a first threshold value received by at least one of the sorter device controller (14) and the system operation controller (3) of the IVD examination room system (1), assigning the first threshold value to the first sample container rack (11a). The method according to claim 1 or 2, wherein at least one of the above is provided.

4. In the operation process, The first threshold value is updated by a corrected first threshold value representing the corrected first threshold number of the sample containers (4), and the corrected first threshold value is different from the first threshold value. The current number of the first sample containers (4) is compared with the corrected first threshold value by the sorter device controller (14). When the current number of the first sample containers (4) is the same as or greater than the corrected first threshold value, the first warning data is output via the output device. The method according to any one of claims 1 to 3.

5. In the operation process, Determining an operation parameter representing at least one of the current operation characteristics of the IVD examination room system (1), such as the current operation characteristics of the sorter device (5) and the current operation characteristics of the IVD devices provided in the IVD examination room system (1), and Determining the corrected first threshold value according to the operation parameter. The method according to claim 4, further comprising the above.

6. The operation parameter is The sample container processing capacity of the sorter device (5), The sample container processing capacity of the IVD examination room system (1), The sample container processing capacity of at least one IVD device (2), The sample container processing capacity of the first processing sub-target, and The sample container processing capacity of the handling device (13). The method according to claim 5, representing at least one operation characteristic selected from the above.

7. The method according to any one of claims 4 to 6, wherein the first threshold value is updated in response to the output of the first warning data via the output device.

8. In the operation process, Assigning a corrected first processing sub-target different from the updated first processing sub-target to the first sample container rack (11a). updating the first threshold value in response to the assignment of the corrected first processing sub-target to the first sample container rack (11a) The method according to any one of claims 4 to 7, further comprising.

9. In the pre-operation process, generating sorter device configuration data representing the assignment of the plurality of processing sub-targets to the plurality of sample container racks (11a, 11b) and the assignment of the first threshold value to the first sample container rack (11a); storing the sorter device configuration data in a storage device assigned to the IVD test room system (1); retrieving the sorter device configuration data from the storage device; providing the sorter device configuration data to the sorter device (5); configuring the sorter device according to the sorter device configuration data The method according to any one of claims 1 to 8, further comprising.

10. The method according to claim 9, wherein the sorter device (5) configuration data is retrieved from the storage device in response to reception of a start request for starting operation of the sorter device (5) in at least one of the system operation controller (3) and the sorter device controller (14).

11. The method according to any one of claims 1 to 10, wherein the configuration of the sorter device (5) in the pre-operation process is at least partially executed by a sorter device (5) layout module that can be functionally connected to at least one of the system operation controller (3) and the sorter device controller (14).

12. The method according to claim 11, wherein the sorter device layout module is provided as a sub-module of the system operation controller (3).

13. assigning the first threshold value to a subset of the receiving holes (12) of the first sample container rack (11a) further comprising The first threshold value represents the number of first threshold values of the sample containers (4) in the first sample container rack (11a), The method according to any one of claims 1 to 12, wherein the number of the first threshold values of the sample containers (4) is smaller than the maximum number of sample containers (4) that can be received in the subset of the receiving holes (12) of the first sample container rack (11a).

14. Providing the plurality of sample container racks (11a, 11b) arranged on a plurality of trays (10) each configured to receive one or more sample container racks (11a, 11b) from the plurality of sample container racks (11a, 11b). The method according to any one of claims 1 to 13, further comprising.

15. A system operation controller (3); A sorter device (5); An IVD test room system (1) comprising: The sorter device (5) is: A plurality of sample container racks (11a, 11b) each provided with a receiving hole (12) for receiving a sample container (4); A handling device configured to pick up a sample container (4) from the receiving hole (12) of the sample container rack (11a, 11b) and place the sample container (4) in the receiving hole (12) of the sample container rack (11a, 11b); A sorter device controller (14) configured to control the operation of the sorter device (5) and connectable to the system operation controller (3); An output device (15) functionally connected to the sorter device controller (14) and configured to output at least one of audio data and video data; Having The IVD test room system (1) is for the operation of the sorter device (5). Configuring the sorter device (5) in a pre-operation process, Assigning the plurality of sample container racks (11a, 11b) to a plurality of processing subtargets executed by the IVD test room system (1) during operation, assigning the first sample container rack (11a) to the first processing subtarget, and assigning the second sample container rack (11b) to a second processing subtarget different from the first processing subtarget, and assigning the plurality of sample container racks (11a, 11b) to a plurality of processing subtargets; Assigning to the first sample container rack (11a) a first threshold value representing a first threshold number of sample containers (4) in the first sample container rack (11a), the first threshold number being smaller than the maximum number of sample containers (4) that can be received in the first sample container rack (11a); Including configuring the sorter device (5). Operating the sorter device (5) in the operation process, placing the sample container (4) in the receiving hole (12) of the first sample container rack (11a) by the handling device (13); determining the first current number of the sample containers (4) received in the first sample container rack (11a) by the sorter device controller (14); comparing the first current number of the sample containers (4) with the first threshold by the sorter device controller (14); when the first current number of the sample containers (4) is the same as or greater than the first threshold, outputting first warning data via the output device (15); operating the sorter device (5) including; An IVD examination room system (1) configured to perform the above.

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