Method for operating a separator 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 comprising providing a sorter device (5) in an IVD laboratory system (1) provided with a system operation controller (3), the sorter device (5) having: a plurality of sample container racks, each provided with a receiving aperture for receiving a sample container (4); a handling device configured to pick up a sample container (4) from the receiving aperture of the sample container holder and to place a sample container (4) in the receiving aperture; 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 classifier device controller and configured to output at least one of audio data and video data. The classifier device (5) is configured in a pre-operation process, the configuration comprising: dispensing the plurality of sample container racks to a plurality of processing sub-targets performed by the IVD laboratory system (1) in operation, wherein a first sample container rack is assigned to a first processing sub-target and a second sample container rack is assigned to a second processing sub-target different from the first processing sub-target; and assigning to the first sample container holder a first threshold indicative of a first threshold number of sample containers (4) in the first sample container holder, wherein the first threshold number of sample containers (4) is less than a maximum number of sample containers (4) receivable in the first sample container holder. The sorter device (5) is operated in an operational procedure comprising: placing, by the handling device, a sample container (4) in the receiving aperture of the first sample container holder; determining, by the classifier device controller, a first current number of sample containers (4) received in the first sample container holder; comparing, by the classifier device controller, the first current number of sample containers (4) to the first threshold value; and outputting first warning data by the output means if the first current number of sample containers (4) is equal to or greater than the first threshold value. Furthermore, the present disclosure provides an IVD laboratory system (1).

Description

[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] In vitro diagnostic (IVD) laboratory systems are used to test / analyze, especially substantially automatically test / analyze samples, such as blood or tissue samples collected from the human body, such as body fluid samples. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person's overall health to help cure, treat or prevent disease. IVD laboratory systems can also be used in precision medicine to determine which patients may benefit from a particular treatment or therapy. In vitro diagnostic tests performed by IVD laboratory systems are typically used in laboratories or other health professional institutions.

[0003] Such an IVD laboratory system may include multiple IVD instruments. The IVD instrument may be provided with multiple IVD components or (e.g., equipment or instrument) modules. For example, the IVD instrument may be a pre-analysis, analysis and / or post-analysis IVD instrument. In an IVD laboratory system, a sample container is typically moved along a processing line for processing. For example, in an IVD laboratory system, an IVD sample container may be moved or repositioned from a first IVD instrument to a second IVD instrument disposed in a processing line. The IVD instrument may provide an IVD workstation or position.

[0004] Document US 9,753,048 B2 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 prepared, an identifier for distinguishing the sample tray is attached to the sample tray, a sample introduction unit is provided with an identifier reading device that reads the identifier of the sample tray that identifies the sample, and information about the sample is switched based on the read identifier of the sample tray.

[0005] Document US2014 / 0294699A1 discloses a sample transfer device, in which samples can be transferred between carriers used for different types of transport. A plurality of trays are provided that can hold sample carriers of transfer destinations, and these trays can be freely grouped.

[0006] Document US 6,255,614 B1 relates to an apparatus including a sample container transfer device, which has: a conveyor unit, which is used to transport a sample container rack; a sample container ID reader, which is used to read the sample container identification number of the sample container rack transported by the conveyor unit; a sample container storage rack, which is used to place a sample container storage rack for storing sample containers; a sample container transfer mechanism, which is used to take the sample container out of the sample container rack and place it in the sample container storage rack; and a control unit, which is used to control the order in which the sample containers are placed in the sample container storage rack. Summary of the invention

[0007] An object of the present disclosure is to provide an improved method for operating a sorter device in an IVD laboratory system and an IVD laboratory system which reduces the risk of interrupting the operation of the IVD laboratory system.

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

[0009] According to one aspect, a method for operating a sorter device in an IVD laboratory system is provided, the method comprising providing a sorter device in an IVD laboratory system provided with a system operation controller, the sorter device having: a plurality of sample container racks, each of which is provided with a receiving hole for receiving a sample container; a handling device configured to pick up sample containers from the receiving holes of the sample container racks and place the sample containers in the receiving holes; 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-operational flow, the sorter device is configured, including: assigning a plurality of sample container racks to a plurality of processing sub-targets performed by an IVD laboratory system in operation, wherein a first sample container rack is assigned to a first processing sub-target and a second sample container rack is assigned to a second processing sub-target different from the first processing sub-target, and assigning a first threshold value indicating a first threshold number of sample containers in the first sample container rack to the first sample container rack, wherein the first threshold number of sample containers is less than a maximum number of sample containers receivable in the first sample container rack. In an operational flow, the sorter device is operated, including: placing a sample container in a receiving hole of the first sample container rack by a handling device, determining a first current number of sample containers received in the first sample container rack by a 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 through an output device if the first current number of sample containers is equal to or greater than the first threshold value.

[0010] According to another aspect, an IVD laboratory system is provided, which includes a system operation controller and a sorter device. The sorter device has the following: a plurality of sample container racks, each of which is provided with a receiving hole for receiving a sample container; a handling device, which is 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; a sorter device controller, which is configured to control the operation of the sorter device and can be connected to the system operation controller; and an output device, which is functionally connected to the sorter device controller and configured to output at least one of audio data and video data. The IVD laboratory system is configured to operate, including: configuring the sorter device in a pre-operation process, including: allocating a plurality of sample container racks to a plurality of processing sub-targets performed by the IVD laboratory system in operation, wherein a first sample container rack is allocated to a first processing sub-target and a second sample container rack is allocated to a second processing sub-target different from the first processing target, and allocating a first threshold value indicating a first threshold number of sample containers in the first sample container rack for receiving sample containers to the first sample container rack. Further, the sorter device is operated in the operation process, including: the handling device places the sample container in the receiving hole of the first sample container rack, the sorter device controller determines the first current number of sample containers received in the first sample container rack, the sorter device controller compares the first current number of sample containers with a first threshold value, and if the first current number of sample containers is equal to or greater than the first threshold value, outputs first warning data through the output device.

[0011] The sorter device can provide storage for multiple sample containers, which, for example, will be processed by one of the IVD instruments of the IVD laboratory system or processed for sorting or long-term storage. One or more sorter devices can be provided in the IVD laboratory system. In the case where multiple sorter devices are provided in the IVD laboratory system, the sorter device can be placed in different positions of the IVD laboratory system. For example, a sorter device can be provided to introduce a sample container into the workflow of the IVD laboratory system. Similarly, the sorter device can be used to store sample containers, thereby leaving a certain workflow in the IVD laboratory system.

[0012] During operation of the sorter device, it is checked whether the number of sample containers currently received in the first sample container rack is lower than or at least equal to a first threshold value. For example, the first threshold value may indicate a value between 70% and 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 even 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) are output by the output device, thereby informing the operator of the IVD laboratory system that the first sample container rack may be completely filled with sample containers in the near future. In response, the operator may initiate the necessary steps or measures to avoid the complete filling of the first sample container rack. This complete filling, i.e., all receiving holes of the first sample container rack have received sample containers, may interrupt further operation or workflow of the IVD laboratory system.

[0013] The first threshold is set in a pre-operation process that occurs before the actual operation of the sorter device, which is part of the operation of the IVD laboratory system. The pre-operation process can be performed, for example, in a design process when setting up the IVD laboratory system. In addition, the pre-operation process can be performed when the IVD laboratory system is restarted after a certain non-operation time.

[0014] The method may further include assigning a second threshold value indicating a second threshold number of sample containers in the second sample container rack to the second sample container rack, wherein the second threshold number of sample containers is less than the maximum number of sample containers that can be received in the second sample container rack, and the second threshold value is different from the first threshold value. The operation of the sorter device in the operation flow may further include the following: placing the sample container in the receiving hole of the second sample container rack by the disposal 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 value by the sorter device controller, and outputting second warning data through the output device if the second current number of sample containers is equal to or greater than the second threshold value. A threshold value may be set or configured for one or more of the sample container racks, indicating an individual threshold number of sample containers that can be received in some sample container racks from the plurality of sample container racks. The threshold value may be set independently for each of the sample container racks. In the operation of the sorter device (of the IVD laboratory system), the current number of sample containers received in the sample container rack to which the threshold value has been assigned is determined and compared with the previously set threshold value.

[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 can be determined multiple times during the operation of the IVD laboratory system. For example, this determination of the current number of sample containers received in the sample container rack can be triggered by a specific event and / or periodically after a certain predetermined time has passed. For example, the determination of the current number of sample containers can be determined every one minute. While the IVD laboratory system is running or being operated, the first and / or second current numbers of sample containers received in the first / second sample container rack can be continuously determined.

[0016] At least one of the following items can be provided for the method: in response to a rack allocation user input received in at least one of a sorter device controller and a system operation controller of the IVD laboratory system, a plurality of sample container racks are allocated to a plurality of processing sub-targets; and in response to a first threshold user input received in at least one of a sorter device controller and a system operation controller of the IVD laboratory system, a first threshold is allocated to a first sample container rack. The rack allocation user input indicates an allocation between at least one sample container rack and a processing sub-target to be allocated to the at least one sample container rack. The user input can be received through a user interface, for example, allowing a user to select among a plurality of processing sub-targets performed in the operation of the IVD laboratory system. For user selection, a menu can be displayed on a display device of the user interface, which allows the user to select a processing sub-target to be allocated to a certain sample container rack.

[0017] In various embodiments, the processing sub-goals may include one or more of the following processing sub-goals: transporting sample containers between IVD instruments, providing sample containers to a refrigerator, providing sample containers to a workflow within an IVD laboratory system, providing sample containers to an IVD analyzer, sorting sample containers, and providing sample containers to a storage location outside of the IVD laboratory system. Sample container racks in a sorter device that are assigned such processing sub-goals may be provided with sample containers to be processed according to one and the same processing sub-goal.

[0018] In the operational flow, the following may be provided: updating the first threshold value by indicating a modified first threshold value of a modified first threshold value number of sample containers, the modified first threshold value being different from the first threshold value; comparing the first current number of sample containers with the modified first threshold value by a sorter device controller; and outputting first warning data by an output device if the first current number of sample containers is equal to or greater than the modified first threshold value. According to this example, the first threshold value initially set or configured may be modified during operation of the IVD laboratory system. The first threshold value may be dynamically modified or updated, thereby adjusting the first threshold value when necessary. The modified first threshold value may be received by user input.

[0019] The second threshold value may be updated by the modified second threshold value in response to updating the first threshold value. For example, if a second sample container rack is to be filled with sample containers after the first sample container rack is completely filled, the first threshold value and the second threshold value may be linked, thereby causing the second threshold value to be updated if the first threshold value is assigned the modified first threshold value as a result of the update.

[0020] In the operation flow, the method may further include: determining an operating parameter indicating at least one of a current operating characteristic of the sorter device and a current operating characteristic of the IVD laboratory system, such as a current operating characteristic of an IVD device provided in the IVD laboratory system; and determining a modified first threshold value according to the operating parameter. The first threshold value is updated by the modified first threshold value according to the operating parameter, so as to adapt the first threshold value according to the actual operation of the IVD laboratory system. For example, if it is determined that the IVD laboratory system switches from the first operating mode to the second operating mode, an update of the first threshold value by the modified first threshold value can be performed in response. The first and second operating modes may, for example, refer to the IVD laboratory system performing different workflow designs.

[0021] The operating parameter may indicate at least one operating characteristic selected from the following: sample container throughput of a sorter device, sample container throughput of an IVD laboratory system, sample container throughput of at least one IVD device, sample container throughput of a first processing sub-target, and sample container throughput of a disposal device. The throughput of a sample container refers to the number of sample containers processed or disposed within a time period, such as the number of sample containers processed or disposed within five minutes or one hour. Different throughput values ​​may be determined based on different time periods applied to determine the throughput value. For example, switching between a first operating mode and a second operating mode for an IVD laboratory system may result in applying different throughput determinations, which in turn may result in an update to the first and / or some other threshold value.

[0022] The first threshold value may be updated in response to the output of the first warning data via the output device. In this example, the updating of the first threshold value by the modified first threshold value is performed in response to the output of the determined first warning data. For example, taking into account the current throughput value, the first threshold value may be increased, thereby allowing a higher number of sample containers to be received in the first sample container rack before the warning data is output. For example, such a measure may be performed if the throughput value is considered to be quite low. This will allow the first threshold value to be increased to a higher level.

[0023] For example, due to a disposal device or a fast-operating clamp, or because the operating system is supplemented with an additional disposal device or clamp, the throughput may be high. In this case, the maximum number of sample containers may be reached faster than usual. In order to allow the operator to react in time after exceeding the threshold value and before reaching the maximum number of sample containers, the threshold value can be set to a lower value. For example, the sample container throughput of the sorter device, the IVD laboratory system, any IVD instrument, the first processing sub-target and / or the disposal device can be constantly monitored, and the monitored data can be maintained in one or more operating parameters. If one or more of these operating parameters exceed the mean value predefined amount of one or more operating parameters, the threshold value can be set to a lower value. For example, the threshold value can be reduced by a predefined amount. This process can be repeated and cause the threshold value to be reduced repeatedly.

[0024] As another example, the throughput may be low due to maintenance or due to problems with the drive motor or due to overall low performance or lack of sample containers in the operating system. In this case, the maximum number of sample containers may be reached more slowly than usual. In order to avoid unnecessary interactions on behalf of the operator, the threshold value can be set to a higher value. Similar to the above example, the sample container throughput can be monitored. If the operating parameter lags behind the mean value predefined amount of one or more operating parameters, the threshold value can be set to a higher value. For example, the threshold value can be increased by a predefined amount. The increased amount can be equal to the reduced amount in the previous example.

[0025] In an operational flow, the method may further include: assigning a revised first processing sub-target different from the first updated processing sub-target to the first sample container rack; and updating the first threshold in response to the assignment of the revised first processing sub-target to the first sample container rack. In this example, the first threshold is revised or updated due to the assignment of the new or different processing sub-target to the first sample container rack. The new or different processing sub-target may mean a different demand for the first sample container rack, which leads to the revision or update of the first threshold.

[0026] In the pre-operational process, the method may further include: generating sorter device configuration data indicating the allocation of multiple sample container racks to multiple processing sub-targets and the allocation of the first threshold to the first sample container rack; storing the sorter device configuration data in a storage device allocated 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. The sorter device configuration data is stored and thereby made available for some additional or later configuration of the sorter device. For example, the sorter device configuration data can be generated and stored in the early stages of generating a design or layout of the IVD laboratory system. Subsequently, when the IVD laboratory system is actually operated 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 may be retrieved from the storage device in response to receiving a start request to start operation of the sorter device in at least one of the system operation controller and the sorter device controller. In response to the received start request to start operation of the sorter device, for example in response to user input, the sorter device configuration data is provided to configure the sorter device. This configuration may be performed at any time when (re)starting the IVD laboratory system.

[0028] The configuration of the sorter device in the pre-operational process can be performed at least in part by a sorter device layout module that can be functionally connected to at least one of the system operation controller and the sorter device controller. The sorter device layout module can be provided by a software module running on one or more processors, and will be configured to generate sorter device configuration data applied to the configuration of the sorter device. The sorter device layout module can be connected to the system operation controller of the IVD laboratory system, which in turn can provide the sorter device configuration data to the sorter device such as the sorter device controller. Alternatively, the sorter device layout module can be directly connected to the sorter device controller.

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

[0030] The method may further include assigning a first threshold value to a subset of receiving holes of the first sample container rack, wherein the first threshold value indicates a first threshold number of sample containers in the first sample container rack, and the first threshold number of sample containers is less than a maximum number of sample containers receivable in the subset of receiving holes of the first sample container rack. In this example, the first threshold value is assigned to a subset of receiving holes of the first sample container rack, rather than to the entire first sample container rack. Another subset of receiving holes of the first sample container rack may have been assigned a different threshold value. Different subsets of receiving holes of the first sample container rack may be assigned to different processing sub-targets. In operation, a fill level (the number of sample containers currently received) is determined independently for the subset of receiving holes. Warning data may be generated independently for the subset of receiving holes when necessary.

[0031] The method may further include providing a plurality of sample container racks disposed on a plurality of trays, each of the plurality of trays being configured to receive one or more sample container racks from the plurality of sample container racks. In an example, similar to the threshold value assigned to the sample container rack, a threshold value may be assigned to a tray carrying one or more sample container racks, the threshold value indicating a threshold number of sample containers for receiving sample containers in the one or more sample container racks located in the tray, wherein the threshold value is less than a maximum number of sample containers receivable in the tray. With respect to generating and outputting warning data, processing and handling of such threshold values ​​assigned to the tray may be performed as already described for the threshold values ​​assigned to the sample container racks.

[0032] The IVD 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 to be processed in the IVD laboratory system. The sample container may be a tube. One or more sample containers may be received in a rack or a disc providing a sample container holder or a carrier. The sample container holder or the carrier may be configured to receive one or more sample containers. The sample container may be configured to receive one or more samples to be processed in the laboratory system. The sample container may be disposed or processed only by a subgroup of the IVD instrument or a single IVD instrument of the IVD laboratory system.

[0033] In the sorter device, a sample container can be picked up from a receiving hole of a sample container rack and placed in the receiving hole.

[0034] The biological sample received in the sample container may include biological material, such as taken from a human or animal body. The biological sample may include body fluids, such as blood, interstitial fluid, urine, saliva, or other types of body fluids. For simplicity, the biological sample is generally referred to herein as just a "sample."

[0035] The sample may potentially include at least one target analyte, such as a molecule, ion, protein, metabolite, pathogen, etc. The presence or absence and / or concentration of one or more analytes in the detection sample is usually one of the tasks of IVD testing. More generally, IVD testing may refer to determining the biological properties of a sample. An IVD test may include performing at least one analytical test on a sample, wherein the analytical test may allow a conclusion to be drawn about the biological properties of the sample. The analytical test may include, for example, adding reagents to the sample, possible detection reactions of the sample and the reagent and / or detecting or not detecting the reaction. The detection of the reaction may include, for example, measuring a sample (or a composite material obtained by using a sample, such as a sample-reagent mixture) physical value, such as a spectrum and / or intensity of radiation reflected / or transmitted through the sample by the sample (or a composite material obtained by using a sample).

[0036] Processing a sample in an IVD laboratory system can, for example, include: transporting the sample (typically in a sample container such as a tube; the sample container can be held in a sample container holder such as a tube rack), performing pre-analytical steps on the sample (e.g., preparation steps such as centrifugation), performing analytical steps on the sample (e.g., adding reagents to the sample and measuring the reaction of the sample with the reagents), and / or performing post-analytical steps on the sample (e.g., storing the sample in a refrigerator for later use).

[0037] An IVD laboratory instrument or IVD laboratory system includes one or more IVD (laboratory) instruments designed for processing samples, such as one or more steps of an expected workflow for executing the sample. Processing samples may include one or more physical processing steps (e.g., moving, mixing, heating, etc.). An IVD instrument may include instrument hardware (e.g., a holder, a reagent storage device, a pipetting device, a heating element, etc.) for processing samples and instrument software designed to operate the instrument hardware. An IVD laboratory instrument may include a control unit designed to control (specifically, manipulate) the operation of the instrument hardware, wherein the instrument software may be designed to be executed using the control unit.

[0038] IVD laboratory instruments are generally classified according to the different types of sample processing steps that they can perform. Transport IVD laboratory instruments are designed to transport samples (sample containers and / or corresponding sample container holders, respectively), for example, from one IVD laboratory instrument to another IVD laboratory instrument. Pre-analysis IVD laboratory instruments are designed to perform pre-analysis steps on samples. Analytical IVD laboratory instruments are designed to perform analytical steps (such as analytical tests) on samples; analytical IVD laboratory instruments may include digital analytical IVD laboratory instruments for performing analytical calculation steps (e.g., medical algorithms). Post-analysis IVD laboratory instruments are designed to perform post-analysis steps on samples. Some IVD laboratory instruments are capable of performing multiple types of sample processing steps, such as pre-analysis steps and analytical steps.

[0039] In an example, the IVD lab-set includes two pre-analytical IVD lab-instruments, five analytical IVD lab-instruments, one post-analytical IVD lab-instrument, and one shipping IVD lab-instrument, wherein the IVD lab-set is designed such that one shipping IVD lab-instrument connects all other IVD lab-instruments.

[0040] The IVD laboratory system may include a transport system configured to transport sample containers in the IVD laboratory system. The transport system may be configured to transport sample containers along a sample container stream. The transport may be fully or substantially automated. The transport system may be supported by user interaction. At least along a segment of the sample container stream, a user may transport the sample container. The user transport may be a routine activity. DETAILED DESCRIPTION

[0041] Next, the embodiments are described with reference to the accompanying drawings by way of example. In the accompanying drawings:

[0042] Figure 1 Schematic diagram of the components or parts of the IVD laboratory system;

[0043] Figure 2 A schematic diagram of a sorter device provided in an IVD laboratory system; and

[0044] Figure 3 Schematic diagram of a method for operating a sorter device in an IVD laboratory system.

[0045] Figure 1A schematic diagram of elements or components of an IVD laboratory system 1 is shown, which includes a plurality of IVD instruments 2 to provide a workflow for analyzing samples and receiving sample containers. An operating system controller 3 is provided, which is configured to control and manage the operation of the plurality of IVD instruments 2 to perform at least one of pre-analysis, analysis, and post-analysis on samples such as blood or tissue samples (e.g., samples of body fluids) that have been collected from a human body.

[0046] The sample container 4 receiving the sample to be analyzed in the IVD laboratory system 1 can be received and stored in the sorter device 5, which can be connected to the workflow between the IVD instruments 2 at any point along the workflow. For example, the sample container 4 can be received in the sorter device 5 from the workflow. Similarly, the sample container 4 can be provided from the sorter device 5 to the workflow established between the IVD instruments 2. One or more sorter devices 5 can be provided for the IVD laboratory system 1.

[0047] Figure 2 A schematic diagram of a sorter device 5 is shown which is provided with a tray 10 carrying a plurality of sample container racks 11a, 11b, each of the plurality of sample container racks being provided with a plurality of receiving holes 12 configured to receive one of the sample containers 5 to be processed by the IVD instrument 2 or having been processed by the IVD instrument 2.

[0048] according to Figure 2 , the sorter device 5 is provided with a handling device 13, which is configured to place the sample container in the receiving hole 12 of the sample container rack 11a, 11b and pick up the sample container 4 from the receiving hole 12. In order to perform such operations of picking up and placing, the handling device 13 is movable across the arrangement of the sample container racks 11a, 11b received on the tray 10.

[0049] The operation of the sorter device 5 is controlled by a sorter device controller 14 which may be connected to the operating system controller 3. Figure 2 , the sorter device controller 14 is connected to a user interface 15 that is configured to output output data (such as audio and / or video data) and receive user input from an operator of the IVD laboratory system 1 .

[0050] Next, about Figure 3 , describing a method for operating a sorter device 5 in an IVD laboratory system 1. In a pre-operational process, the sorter device 5 is configured, including allocating a plurality of sample container racks 11a, 11b to a plurality of processing sub-targets performed by the operating IVD laboratory system 1 (step 30). When operating the IVD laboratory system 1, a plurality of different processing sub-targets may be performed.

[0051] Each of the plurality of sample container racks 11a, 11b is assigned one of the processing sub-targets. The first sample container rack 11a is assigned a first processing sub-target. The second sample container rack 11b is assigned a second processing sub-target different from the first processing sub-target. Based on this assignment, different sample container racks 11a, 11b will receive sample containers 4 for storage through the handling device 13, and the sample containers will be processed according to the processing sub-targets assigned to the corresponding sample container racks 11a, 11b. Therefore, in this example, the sample container rack 11a or 11b and the sample container 4 received in the receiving hole 12 of such sample container rack 11a or 11b are assigned the same processing sub-target.

[0052] A handling device 13 movable across the area of ​​the tray 10 receiving the sample container racks 11 a , 11 b is configured to pick up and place the sample container 4 .

[0053] Processing a sample in the IVD laboratory system 1 (e.g., providing processing sub-goals) can, for example, include: transporting the sample (provided in a sample container 4 such as a tube), performing pre-analytical steps on the sample (e.g., preparation steps such as centrifugation), performing analytical steps on the sample (e.g., adding reagents to the sample and measuring the reaction of the sample with the reagents), and / or performing post-analytical steps on the sample (e.g., storing the sample in a refrigerator for later use).

[0054] The IVD instrument 2 is designed to process samples, such as one or more steps of an expected workflow for executing the sample. Processing the sample may include one or more physical processing steps (e.g., moving, mixing, heating, etc.). The IVD instrument 2 may include instrument hardware (e.g., a holder, a reagent storage device, a pipetting device, a heating element, etc.) for processing the sample and instrument software designed to operate the instrument hardware. The IVD instrument 2 may include a control unit designed to control (particularly, manipulate) the operation of the instrument hardware, wherein the instrument software may be designed to be executed using the control unit.

[0055] Further, according to step 31, the first sample container rack 11a is assigned a first threshold value indicating a first threshold number of sample containers 4 to be received in the first sample container rack 11a. This first threshold number of sample containers 4 is less 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.

[0056] Optionally, in step 32, sorter device configuration data indicating the allocation of multiple sample container racks 11a, 11b to multiple processing sub-targets and the allocation of the first threshold to the first sample container rack 11a can be generated. Such sorter device configuration data can be stored in a storage device (not shown) allocated to the IVD laboratory system 1. If the sorter device configuration data is generated and stored, then in step 33, the sorter device configuration data can be optionally retrieved from the storage device and provided to configure the sorter device 5. For example, the sorter device configuration data can be generated and stored in the early stages of generating the design or layout of the IVD laboratory system 1. Subsequently, when the IVD laboratory system 1 is actually operated for sample handling and processing, the sorter device configuration data can be received and applied to the configuration of the sorter device 5.

[0057] In the operation flow for operating the sorter device 5 (while operating or running 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 this operation, in step 34, the first current number of sample containers 4 currently received in the first sample container rack 11a is determined one or more times by the sorter device controller 14.

[0058] In step 35, the first current number of sample containers 4 is compared with the first threshold value by the sorter device controller 14. If the first current number of sample containers 4 is equal to or greater than the first threshold value, first warning data is outputted by the user interface 15 via at least one of output audio data and video data (step 35). The first warning data informs the operator of the IVD 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 full of sample containers 4. In response, the operator can take necessary measures to avoid the complete filling of the first sample container rack 11a, which may cause an interruption in the operation of the IVD laboratory system 1. For example, the operator can assign another sample container rack to the same sub-target to which the first sample container rack 11a is assigned, thereby providing additional storage capacity for the sample containers 4 when the first sample container rack 11a is fully filled. Interruptions in the operation of the sorter device 5 and the IVD laboratory system 1 are avoided.

[0059] The method previously described with respect to the first sample container rack 11 a may be applied to one or more additional sample container racks from the plurality of sample container racks 11 a , 11 b on the tray 10 .

[0060] The threshold value assigned to one of the sample container racks 11a, 11b may be updated or modified during operation of the sorter device 5 according to a certain operating characteristic determined for the IVD laboratory system 1. For example, if it is determined that the IVD laboratory system 1 switches from a first operating mode to a second operating mode, an update of the first threshold value by a modified first threshold value may be performed in response. The first and second operating modes may, for example, refer to the IVD laboratory system 1 performing different workflow designs.

Claims

1. A method for operating a sorter device (5) in an IVD laboratory system, the method comprising: - providing a sorter device (5) in an IVD laboratory system (1) provided with a system operation controller (3), the sorter device (5) having - a plurality of sample container racks (11a, 11b), each of which is 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 to place the sample container (4) in the receiving hole, - a sorter device controller (14) configured to control the operation of the sorter device (5) and connectable to the system operation controller (3), and - 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; - configuring the sorter device (5) in a pre-operation process, comprising - assigning the plurality of sample container racks (11a, 11b) to a plurality of processing sub-targets performed by the IVD laboratory system (1) in operation, wherein a first sample container rack (11a) is assigned to a first processing sub-target and a second sample container rack (11b) is assigned to a second processing sub-target different from the first processing sub-target, and - assigning a first threshold value indicating a first threshold number of sample containers (4) in the first sample container rack (11a) to the first sample container rack (11a), wherein the first threshold number of sample containers (4) is less than a maximum number of sample containers (4) receivable in the first sample container rack (11a); and - operating the sorter device (5) in an operating process, comprising - placing the sample container (4) in the receiving hole (12) of the first sample container rack (11a) by means of the handling device (13), - determining, by means of the sorter device controller (14), a first current number of sample containers (4) received in the first sample container rack (11a), - comparing, by means of the sorter device controller (14), the first current number of sample containers (4) with the first threshold value, and - if the first current number of sample containers (4) is equal to or greater than the first threshold value, first warning data are output via the output device (15).

2. The method of claim 1, further comprising assigning to the second sample container rack a second threshold value indicating a second threshold number of sample containers (4) in the second sample container rack (11b), wherein - the second threshold number of sample containers (4) is less than the maximum number of sample containers (4) receivable in the second sample container rack (11b), - the second threshold is different from the first threshold, and - the operation of the sorter device (5) in the operation flow further comprises - placing the sample container (4) in the receiving hole (12) of the second sample container rack (11b) by means of the handling device, - determining, by means of the sorter device controller (14), a second current number of sample containers (4) received in the second sample container rack (11b), - comparing, by means of the sorter device controller (14), the second current number of sample containers (4) with the second threshold value, and - if the second current number of sample containers (4) is equal to or greater than the second threshold value, second warning data are output via the output device.

3. The method according to claim 1 or 2, wherein at least one of the following is provided: - allocating the plurality of sample container racks (11a, 11b) to the plurality of processing sub-targets in response to a rack allocation user input received in at least one of the sorter device controller (14) and the system operation controller (3) of the IVD laboratory system (1); and - in response to a first threshold user input received in at least one of the sorter device controller (14) and the system operation controller (3) of the IVD laboratory system (1), assigning the first threshold to the first sample container rack (11a).

4. The method according to at least one of the preceding claims, wherein in the process flow, - the first threshold is updated by a modified first threshold indicating a modified first threshold number of sample containers (4), the modified first threshold being different from the first threshold; - comparing, by means of the sorter device controller (14), the first current number of sample containers (4) with the modified first threshold value; and - if the first current number of sample containers (4) is equal to or greater than the modified first threshold value, outputting the first warning data via the output device.

5. The method according to claim 4, further comprising: In the described operation flow, - determining operating parameters, said operating parameters being indicative of at least one of: current operating characteristics of said sorter device (5); and current operating characteristics of said IVD laboratory system (1), such as current operating characteristics of an IVD device provided in said IVD laboratory system (1); and - determining said modified first threshold value as a function of said operating parameter.

6. The method of claim 5, wherein the operating parameter indicates at least one operating characteristic selected from the group consisting of: - the sample container throughput of the sorter device (5), - the sample container throughput of the IVD laboratory system (1), - a sample container throughput of at least one IVD instrument (2), - the sample container throughput of the first processing sub-goal, and - The sample container throughput of the handling device (13).

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

8. The method according to at least one of claims 4 to 7, further comprising: In the described operation flow, - assigning to said first sample container rack (11a) a modified first processing sub-objective different from a first updated processing sub-objective; and - Updating said first threshold in response to said assignment of said modified first processing sub-target to said first sample container rack (11a).

9. The method according to at least one of the preceding claims, further comprising: In the pre-operation process, - generating sorter device configuration data, the sorter device configuration data indicating the assignment of the plurality of sample container racks (11a, 11b) to the plurality of processing sub-targets and the assignment of the first threshold to the first sample container rack (11a); - storing the sorter device configuration data in a storage device assigned to the IVD laboratory system (1); - retrieving said sorter device configuration data from a storage device; - providing the sorter device (5) with the sorter device configuration data; and - configuring said sorter device according to said sorter device configuration data.

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

11. A method according to at least one of the preceding claims, wherein the configuration of the sorter device (5) in the pre-operation process is at least partially performed 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 submodule of the system operation controller (3).

13. The method according to at least one of the preceding claims, further comprising assigning the first threshold value to a subgroup of the receiving holes (12) of the first sample container rack (11a), wherein - the first threshold value indicates a first threshold number of sample containers (4) in the first sample container rack (11a), and The first threshold number of sample containers (4) is smaller than the maximum number of sample containers (4) receivable in the subset of receiving holes (12) of the first sample container rack (11a).

14. The method according to at least one of the preceding claims, further comprising providing the plurality of sample container racks (11a, 11b) arranged on a plurality of trays (10), each of the plurality of trays being configured to receive one or more sample container racks (11a, 11b) from the plurality of sample container racks (11a, 11b).

15. An IVD laboratory system (1), comprising: - System operation controller (3); as well as - a sorter device (5) having - a plurality of sample container racks (11a, 11b), each of which is 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 to place the sample container (4) in the receiving hole, - a sorter device controller (14) configured to control the operation of the sorter device (5) and connectable to the system operation controller (3), and - 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; Wherein the IVD laboratory system (1) is configured for the operation of the sorter device (5) as described below: - configuring the sorter device (5) in a pre-operation process, comprising - assigning the plurality of sample container racks (11a, 11b) to a plurality of processing sub-targets performed by the IVD laboratory system (1) in operation, wherein a first sample container rack (11a) is assigned to a first processing sub-target and a second sample container rack (11b) is assigned to a second processing sub-target different from the first processing sub-target, and - assigning a first threshold value indicating a first threshold number of sample containers (4) in the first sample container rack (11a) to the first sample container rack (11a), wherein the first threshold number of sample containers (4) is less than a maximum number of sample containers (4) receivable in the first sample container rack (11a); and - operating the sorter device (5) in an operating process, comprising - placing the sample container (4) in the receiving hole (12) of the first sample container rack (11a) by means of the handling device (13), - determining, by means of the sorter device controller (14), a first current number of sample containers (4) received in the first sample container rack (11a), - comparing, by means of the sorter device controller (14), the first current number of sample containers (4) with the first threshold value, and - if the first current number of sample containers (4) is equal to or greater than the first threshold value, first warning data are output via the output device (15).

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