Method for operating an in vitro diagnostic laboratory system and in vitro diagnostic laboratory system - Patent Application 20070122999

Abstract

The present disclosure relates to a method for operating an in vitro diagnostic (IVD) laboratory system, the IVD laboratory system including a housing (12) with an opening (12a), an actuator device (10) disposed within the housing (12) for processing sample containers, a cover (11) configured to cover the opening (12a), a cooling device (14) configured to cool the sample containers, and a cooling device control unit (15) configured to control operation of the cooling device (14). The method includes determining whether the cover (11) is open, determining whether the cooling device control unit (15) is activated, disabling operation of the actuator device (10) in a normal system mode based on at least one of the cover (11) being open and the cooling device control unit (15) not being activated, and enabling operation of the actuator device (10) in a bypass system mode based on the cover (11) being open and the cooling device control unit (15) being activated.

Description

[Technical Field]

[0001] The present disclosure relates to a method for operating an in vitro diagnostic (IVD) laboratory system. Further, the present disclosure relates to an IVD laboratory system. [Background technology]

[0002] IVD laboratory systems are known that comprise laboratory devices configured to perform pre-analytical, analytical and post-analytical procedures on sample containers containing samples to be processed in the laboratory system, and safety mechanisms are typically provided for operator safety.

[0003] For example, U.S. Patent No. 6,589,789 relates to an automated apparatus for loading a centrifuge, where tubes are provided to the centrifuge via an automatic routing system. Safety doors are provided to prevent an operator from reaching into the stations. U.S. Patent Application Publication No. 2009 / 0180931 discloses an integrated robotic sample transfer device and components used to transfer small samples of material from one registration location to another.

[0004] EP 2148205 discloses a laboratory device for handling sample tubes in a storage compartment, as well as an automated tube identification system. U.S. Pat. No. 9,316,662 relates to an automatic analyzer that includes a transport mechanism for transporting samples, an analytical unit for analyzing the samples, and an apparatus cover that covers the movable mechanism including the transport mechanism. The automatic analyzer includes an interlock mechanism and an interlock release mechanism.

[0005] WO 2018 / 230198 relates to an automatic analyzer for analyzing the amount of components contained in samples such as blood and urine, and an interlock mechanism for controlling the opening and closing of the device cover.

[0006] The Beckman Coulter UniCel DxH 800 Coulter Cellular Analysis System User Manual (March 2009) provides instructions for using the blood specimen processing module with the system manager. The module has a housing, an actuator, and a cover. When the system message "Cover Open" occurs, the SPM (Specimen Processing Module) immediately stops operation.

[0007] US Patent No. 11,185,865 relates to a system and method for refrigerated storage of control and standard materials, utilizing a refrigerant storage assembly having an insulated housing and door assembly, a thermoelectric cooler, and a refrigerated base assembly having a metal plate thermally coupled to the cooler, one or more sensors, and a plurality of receptacles for receiving fluid tubing. The refrigerated storage provides a refrigerated environment suitable for storage of control and standard fluids for several days. Summary of the Invention

[0008] It is an object of the present disclosure to provide a method for operating an IVD laboratory system and an IVD laboratory system that provides improved safety.

[0009] To solve this problem, there is provided a method for operating an IVD laboratory system according to independent claim 1. Furthermore, there is provided an IVD laboratory system according to independent claim 15. Further embodiments are disclosed in the dependent claims.

[0010] According to one aspect, a method for operating an IVD laboratory system is provided. The IVD laboratory system includes a housing with an opening, an actuator device disposed within the housing for processing sample containers, a cover configured to cover the opening, a chiller configured to cool the sample containers, and a chiller control unit configured to control operation of the chiller. The method includes determining whether the cover is open, determining whether the chiller control unit is activated, disabling operation of the actuator device in a normal system mode based on at least one of the cover being open and the chiller control unit not being activated, and enabling operation of the actuator device in a bypass system mode based on the cover being open and the chiller control unit being activated.

[0011] According to another aspect, there is provided an IVD laboratory system comprising: a housing having an opening; an actuator device disposed within the housing for processing sample containers; a cover configured to cover the opening; a chiller configured to cool the sample containers; and a chiller control unit configured to control operation of the chiller, the system being configured to: determine whether the cover is open; determine whether the chiller control unit is activated; disable operation of the actuator device based on at least one of the cover being open and the chiller control unit not being activated in a normal system mode; and enable operation of the actuator device based on the cover being open and the chiller control unit being activated in a bypass system mode.

[0012] Thus, the method may include disabling operation of the actuator device based on the cover being open and disabling operation of the actuator device based on the cooling device control unit not being activated. The method may include determining whether the cover is open or closed and / or determining whether the cooling device control unit is activated or not.

[0013] The method may further include enabling operation of the actuator device in the normal system mode based on the cover being closed and the cooling device control unit being activated, and / or disabling operation of the actuator device in the bypass system mode based on at least one of the cover being closed and the cooling device control unit not being activated.

[0014] The IVD laboratory system may include a locking device configured to lock the cover. The method may include determining whether the locking device is locked (or unlocked) and / or disabling operation of the actuator device in a normal system mode based on the locking device being unlocked. The method may further include enabling operation of the actuator device in the normal system mode based on the cover being closed, the locking device being locked, and the chiller control unit being activated.

[0015] The method may further include disabling operation of the actuator device in the bypass system mode based on the locking device being locked.The method may include enabling operation of the actuator device in the bypass system mode based on the cover being open, the locking device being unlocked, and the cooling device control unit being activated.

[0016] Determining whether the cover is open may be performed via a cover sensor, which may be provided, for example, in the locking device. The locking device may include a locking device sensor configured to determine whether the locking device is locked. The locking device may include a solenoid lock.

[0017] The method may further include switching between the normal system mode and the bypass system mode by a switching device of the IVD laboratory system, preferably by user operation of the switching device of the IVD laboratory system. The switching device may preferably be a key switch configured to accept a key for switching. The switching device may include a normally open output and a normally closed output.

[0018] Determining whether the refrigerator control unit is operational includes repeatedly transmitting a heartbeat signal to a monitoring unit of the IVD laboratory system and / or determining that the refrigerator control unit is not operational after the time since the last heartbeat signal was received by the monitoring unit exceeds a timeout threshold.

[0019] The timeout threshold may be between 0.1 seconds and 20 seconds, preferably between 1 second and 10 seconds, more preferably between 4 seconds and 6 seconds. The monitoring unit may be implemented as an integrated circuit and / or a microcontroller.

[0020] The heartbeat signal may be transmitted from the cooling device control unit at a heartbeat signal time interval of preferably between 0.1 and 20 seconds, preferably between 1 and 10 seconds, and more preferably between 4 and 6 seconds. Additionally or alternatively, the monitoring unit may transmit a probe signal to the cooling device control unit. After receiving the probe signal, the cooling device control unit may transmit a response signal. This allows the cooling device control unit to be determined to be inoperative after the time since transmission of the probe signal exceeds a response timeout threshold. The response timeout threshold may be between 0.1 and 20 seconds, preferably between 1 and 10 seconds, and more preferably between 4 and 6 seconds.

[0021] The method may include controlling the refrigerator with a second refrigerator control unit (different from the refrigerator control unit) upon determining that the refrigerator control unit is not operational. The IVD laboratory system may include a second refrigerator control unit configured to control operation of the refrigerator.

[0022] In particular, upon determining that the chiller control unit is not operational, a reset signal may be sent from the monitoring unit to the latch, after which the latch preferably sends a low status output to transfer control to a second chiller control unit.

[0023] The method may further include controlling the cooling device with a variable cooling capacity (control with adjustment of the cooling capacity) by a cooling device control unit and / or controlling the cooling device with a fixed cooling capacity by a second cooling device control unit.

[0024] The fixed cooling capacity may be the maximum cooling capacity of the cooling device, or may be fixed between 80% and 100% of the maximum cooling capacity of the cooling device.

[0025] The cooling device may comprise an air cooling device, e.g., a fan or multiple fans. Controlling the cooling device by the cooling device control unit may thus include (variably) controlling the fan speed. Controlling the cooling device by the second cooling device control unit may include keeping the fan at a fixed fan speed, e.g., a maximum fan speed.

[0026] The method may comprise cooling the sample vessel by means of a cooling device 14, in particular a fan or fans.

[0027] The cooling device control unit may be implemented in software and / or the second cooling device control unit may be implemented in hardware.

[0028] For example, the cooling device control unit may comprise, or be part of, a data processing device (e.g., comprising a general-purpose processor) that includes cooling device control software (in a memory of the data processing system) for controlling the operation of the cooling device. The second cooling device control unit may comprise dedicated control circuitry for controlling the operation of the cooling device.

[0029] Disabling operation of the actuator device may include stopping the actuator device upon determining that the actuator device is at least partially moving. Further, disabling operation of the actuator device may include stopping movement of the sample container upon determining that the actuator device is moving the sample container. Disabling operation of the actuator device may include applying a brake device configured to stop and / or slow and / or prevent (mechanical) movement of / within the actuator device and / or movement of the sample container.

[0030] Disabling operation of the actuator device may include interrupting power to the actuator device. Enabling operation of the actuator device may include supplying power to the actuator device.

[0031] Disabling (enabling) the operation of the actuator device may include disabling (enabling) an actuator device control unit (actuator device controller) configured to control the operation of the actuator device. The actuator device control unit may comprise a plurality of actuator device control subunits, in particular motor drivers and / or motor controllers. The actuator device control subunits may be implemented as separate integrated circuits (ICs). In particular, a first device control subunit may be a motor driver IC and a second device control subunit may be a motor (servo) controller IC. The first device control subunit and the second device control subunit may be arranged in series.

[0032] The actuator device may comprise at least one moving device (moving part), preferably at least one of a sample container transport device, a sample container dispensing device, a sample container analyzing device, and a motor, and may particularly comprise at least one of a stepper motor, a servo motor, a rotor, a gripper arm, a conveyor belt, and a magnetic actuator configured to magnetically move the sample container.

[0033] The actuator device may be configured to move the sample vessel.

[0034] The method may include, in the normal state mode, disabling operation of the actuator device further based on at least one of an actuator device control unit configured to control operation of the actuator device being in a reset state, the actuator device control unit being in a freeze state, and an emergency user input device being in an actuated state.

[0035] The actuator device control unit may comprise, for example, a motion control chip. The emergency user input device may comprise an emergency button and / or an emergency switch. The emergency user input device may be operable by a user.

[0036] The method may include disabling the actuator device based on a fault from one of the cover, the locking device, the cooling device control unit, the actuator device control unit, and the emergency user input device.

[0037] The method may include bypassing a signal failure of a locking device signal in a bypass system mode, and in particular not disabling the actuator device in response to a locking device signal failure in the bypass mode. The method may include not bypassing a signal failure of a locking device signal in a normal system mode.

[0038] The method may further include determining disabling and enabling operation of the actuator device using a logic circuit that includes the state of the cover, the state of the cooling device control unit (the cooling device monitoring control signal), and the state of the system mode as logic inputs and the state of the actuator device as a logic output.

[0039] The logical input may include a logical state (binary state, binary value variable). For example, the logical state may represent one of: activated / deactivated, open / closed, activated / deactivated, enabled / disabled, and true / false.

[0040] The logical inputs may include at least one of a controller freeze state of an actuator device control unit configured to control the actuator device, a controller reset state of the actuator device control unit, a state of an emergency user input device, a state of a cooling device control unit, a state of a (first and / or second) cover, a state of a (first and / or second) locking device, a (first and / or second) bypass state representing a system bypass mode, and a state of a safety user input device.

[0041] The logic inputs (input signals) may preferably include redundant logic states for detecting faults in the respective input units / devices and / or wiring therefrom. For example, first and second cover states, and / or first and second locking device states, and / or first and second bypass states may be provided.

[0042] The actuator device may be disabled based on at least one of the first and second cover states indicating that the cover is open. Further, the actuator device may be disabled based on at least one of the first and locking device states indicating that the locking device is unlocked.

[0043] The actuator device may be disabled based on the first bypass state being different from the second bypass state. In particular, the actuator device may be disabled based on the first bypass state indicating bypass and the second bypass state not indicating bypass. Furthermore, the actuator device may be disabled based on the first bypass state not indicating bypass and the second bypass state indicating bypass.

[0044] The logic circuit may comprise logic gates, in particular at least one of AND gates, OR gates and NOT gates. A logic input may be processed using the logic gates, which preferably result in a logic output.

[0045] The logic circuit may be configured to respond to a single-state fault condition. Operation of the actuator device may be disabled based on the single-state fault condition.

[0046] The logic circuit may be implemented in an electronic circuit using electronic components. Each logic gate may be implemented using a corresponding electronic component in the electronic circuit. Generally, the method may be performed on a data processing device. The data processing device may comprise the electronic circuit. The IVD laboratory system may comprise the data processing device and / or the electronic circuit.

[0047] The IVD laboratory system may include a housing. At least one or each of the cover, the cooling device, the cooling device control unit, and the locking device may be disposed in or within the housing. The opening may be configured to provide physical user access to the actuator device. The cover may be configured to prevent physical user access to the actuator device. The cover may be, for example, a door, a window, or a sleeve.

[0048] IVD laboratory systems may be configured to test and / or analyze samples, such as blood or tissue samples taken from the human body, e.g., samples of bodily fluids, particularly in an essentially automated manner. In vitro diagnostics can detect diseases and other conditions and can be used to monitor an individual's overall health to aid in the treatment, management, or prevention of disease. IVD laboratory systems may 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 IVD laboratory systems may be used in a laboratory or other medical professional setting.

[0049] An IVD laboratory system may include one or more IVD devices. An IVD device may include multiple IVD components or (e.g., devices or instrument) modules. An IVD device may be, for example, a pre-analytical, analytical, and / or post-analytical IVD device. An IVD device may be moved and / or controlled by an actuator device. In an IVD laboratory system, a sample container may be moved along a processing line for processing. For example, a sample container may be moved or relocated from a first IVD device to a second IVD device provided in a processing line within the IVD laboratory system. An IVD device may provide an IVD work station or location.

[0050] The (biological) sample received in the sample container may include biological material taken from, for example, a human or animal body. The sample may include a bodily fluid, such as blood, interstitial fluid, urine, saliva, or other type of bodily fluid.

[0051] A sample can potentially contain at least one analyte of interest, such as a molecule, ion, protein, metabolite, pathogen, etc. One role of an IVD test may be to detect the presence and / or concentration of one or more analytes in a sample. More generally, an IVD test can refer to revealing biological characteristics of a sample. An IVD test can include performing at least one analytical test on the sample, which can allow conclusions to be drawn regarding the biological characteristics of the sample. An analytical test can include, for example, adding a reagent to the sample, a possible detectable reaction between the sample and the reagent, and / or detecting or not detecting this reaction. Detecting a reaction can include, for example, measuring a physical value of the sample (or a complex obtained by using the sample, such as a sample-reagent mixture), 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).

[0052] Sample processing may include, for example, transporting the sample (typically in a sample container such as an IVD tube, which may be held in a sample container holder, such as a tube rack), performing a pre-analytical step on the sample (e.g., a preparatory step such as centrifugation), performing an analytical step on the sample (e.g., adding a reagent to the sample and measuring a reaction between the sample and the reagent), and / or performing a post-analytical step on the sample (e.g., storing the sample in a refrigerator for later use). Sample processing may include one or more physical processing steps (e.g., moving, mixing, heating, etc.).

[0053] The embodiments described above in relation to a method for operating an IVD laboratory system may be provided correspondingly for an IVD laboratory system.

[0054] Description of Further Embodiments In the following, embodiments will be described by way of example with reference to the figures. [Brief explanation of the drawings]

[0055] [Figure 1] 1 shows a diagram of an IVD laboratory system. [Figure 2] 1 shows a diagram of a method for operating an IVD laboratory system. [Figure 3] 1 shows a diagram of a truth table for the logic circuitry of an IVD laboratory system. [Figure 4] 1 shows a diagram of a logic circuit. [Figure 5] 1 shows a truth table diagram for normal system modes. [Figure 6] 1 shows a truth table diagram for bypass system modes. [Figure 7] 1 shows a diagram of a cooling device control circuit. DETAILED DESCRIPTION OF THE INVENTION

[0056] FIG. 1 shows a diagram of an IVD laboratory system. The IVD laboratory system includes an actuator device 10 for processing sample containers (e.g., transporting and / or performing analytical (pre-analytical) steps). The sample containers are configured to accommodate samples to be processed or treated for at least one of pre-analysis, analysis, and post-analysis in the IVD laboratory system. A cover 11 is provided, for example, on a housing 12, to cover an opening 12a of the housing 12 and / or to cover the actuator device 10. The cover 11 may be in a closed state so that a user (operator) cannot access the actuator device 10 from outside the housing 12. Furthermore, the cover 11 may be in an open state (dashed line) to allow a user to access the actuator device 10. A locking device 13 is provided to lock the cover 11 and thus prevent the closed cover 11 from being opened. A cooling device (chiller) 14 is provided to cool the sample containers. A (first) cooling device control unit 15 and a second cooling device control unit 16 are configured to control the operation of the cooling device 14. The second cooling device control unit 16 controls the cooling device 14 only when the (first) cooling device control unit 15 is not operating.

[0057] An actuator device control unit (operation control unit) 17 is configured to control and / or enable and / or disable the operation of the actuator device 10. The decision to enable or disable the actuator device 10 may be made in a data processing device 18, e.g., an electronic circuit. The actuator device control unit 17 may be part of the data processing device 18. An emergency user input device 19, such as an emergency switch or button, may be provided. As soon as the emergency user input device is activated (e.g., by pressing the emergency button or toggling the emergency switch), the operation of the actuator device 10 is disabled.

[0058] The disabling or enabling of the actuator device 10 depends on the system (operation) mode of the IVD laboratory system. When the IVD laboratory system is in normal system mode, operation of the actuator device 10 is disabled based on the cover 11 being open or the refrigerator control unit 15 not being operational. In other words, in normal system mode, operation of the actuator device 10 is disabled based on the cover 11 being open and operation of the actuator device 10 is disabled based on the refrigerator control unit 15 not being operational.

[0059] In contrast, in bypass system mode, operation of the actuator device 10 is disabled based on the cover 11 being closed or the chiller control unit 15 not being activated. Table 1 below shows the enabling or disabling of the actuator device 10 based on various states of the system, cover 11, and chiller control unit 15.

[0060] [Table 1]

[0061] As shown in Table 1, the highest priority is assigned to the state of the chiller control unit (software state): whenever the chiller control unit 15 is not working (e.g. due to a software failure), the actuator device 10 is disabled, even if the bypass is activated.

[0062] The state of the cover may be fixed by the state of the locking device, i.e., opening the cover 11 may correspond to unlocking the locking device 13, and closing the cover 11 may correspond to locking the locking device 13. In this case, the state of the cover also represents the state of the locking device. When the cover 11 is in the closed state and the bypass is activated, the actuator device 10 is disabled to prevent a maintenance key (e.g., for switching between normal and bypass system modes) from being left inside the housing 12.

[0063] The decision to disable and enable operation of the actuator device 10 can be performed using a logic circuit comprising a plurality of logical (binary) input states and actuator device states as logical (binary) output states. In particular, eleven input states may be provided, including a controller freeze state of the actuator device control unit 17, a controller reset state of the actuator device control unit 17, an emergency user input device state, a cooling device control unit state, a first cover state, a second cover state, a first locking device state, a second locking device state, a first bypass state, a second bypass state, and a safety user input device state.

[0064] Thus, a method for operating an IVD laboratory system may include the steps shown in Figure 2. In a first step 20, an actuator device 10 for processing sample containers, a cover 11 configured to cover the actuator device 10, a chiller 14 configured to cool the sample containers, and a chiller control unit 15 configured to control the operation of the chiller 14 are provided. In a first step 21, it is determined whether the cover 11 is open, and in a second step 22, it is determined whether the chiller control unit 15 is operating. In a third step 23, if the system is in a normal system mode, operation of the actuator device 10 is disabled based on at least one of the cover 11 being open and the chiller control unit 15 not being operating, and if the system is in a bypass system mode, operation of the actuator device 10 is enabled based on the cover 11 being open and the chiller control unit 15 being operating.

[0065] The electronic circuitry disables the actuator device control unit when the cover 11 is open, enabling bypass for maintenance via a switching device 19a (e.g., a key switch). Activating the key switch places the IVD laboratory system in bypass system mode (maintenance mode). The electronic circuitry considers the state of the chiller control unit 15 (software) via a monitoring control signal from the monitoring unit. When the chiller control unit software is running, it can control the chiller 14. In the event of a software error in the chiller control unit, the chiller 14 is driven at maximum cooling capacity (e.g., with the fan at full speed) as a precaution against excessive temperatures. In the event of a software failure, hardware protection freezes all operations related to the actuator device 10. Furthermore, if the hardware logic for the lock device state fails, the cover state may be used, and vice versa, contributing to further redundancy.

[0066] 3, which illustrates a truth table for the logic circuit, shows input states corresponding to a controller freeze state of the actuator device control unit 17, a controller reset state of the actuator device control unit 17, an emergency user input device state, a cooling device control unit state, a first cover state, a second cover state, a first locking device state, a second locking device state, a first bypass state, a second bypass state, and a safety user input device state, respectively. STP_ALL_NFREEZE_MCU, STP_ALL_NRST(MCU), EMERGENCY_SWITCH_GPIO, FANS_STATE_GPIO, Door1_STATE_GPIO, Door2_STATE_GPIO, Lock1_STATE_GPIO, Lock2_STATE_GPIO, SAFETY_BYPASS1_GPIO, SAFETY_BYPASS2_GPIO, and SAFETY_SWITCH_PRESENT_GPIO, or denoted as "a" through "k".

[0067] The input states are processed using logic operations that result in intermediate states "l" through "p" (denoted as "d' and c," "e and !f / DOOR_state_GPIO," "g and h / LOCK_STATE_GPIO," "m and n," and "o'k'ij+oki'j'") and output states "q" through "s" (denoted as "l and p / SAFE_STATE_ENGAGED," "a and q / STP_ALL_NFREEZE," and "(a and q)' / STP_ALL_ENN"). The STP_ALL_NFREEZE signal may be sent to a motor controller IC pin (NFREEZE pin), and the STP_ALL_ENN signal may be sent to a motor driver IC pin (ENN pin). STP_ALL_ENN provides an additional signal to disable the actuator device 10 and is used in series with the motor controller IC.

[0068] 11 logic inputs, 2 11 3 shows the relevant input state combinations that the actuator device 10 is enabled (see "Motor State" (Actuator Device State) column) for the normal system mode and the bypass system mode.

[0069] The normal system state, in which the motor is additionally enabled (the motor can be operated), occurs when the actuator device control unit (e.g., motion control chip) is not in a reset or frozen state, the cooling device control unit 15 software is running, the emergency e-stop button is not pressed, the housing 12 is closed and locked (i.e., the cover 11 is closed and the locking device 13 is locked), and the bypass is not activated. Figure 3 shows one normal system mode combination and multiple bypass system mode combinations, since the bypass results in the locking device 13 being unlocked and the cover 11 being ignored when it is open. When the cover 11 is closed and the bypass is activated, the actuator device 10 is disabled to prevent a maintenance key from being left inside the housing 12.

[0070] An efficient logic circuit for achieving the truth table according to Figure 3 is shown in Figure 4. Input states are provided at input ports 30 and processed by logic gates 41-43 to yield intermediate states. Logic gate 31 corresponds to an AND gate, logic gate 42 corresponds to an OR gate, and logic gate 43 corresponds to a NOT gate. Output states are provided at output port 44.

[0071] Single fault conditions are handled by the logic circuitry as shown in the truth tables according to Figure 5 (normal state mode) and Figure 6 (bypass state mode). In particular, Figures 5 and 6 show various situations when an input error (indicated by boxes 50, 60) occurs and the situations regarding enabling (including bypass) or disabling of actuator device 10 as shown in the "Motor State" column. In Figure 5, normal system states are shown in the first row, and eleven single fault conditions (combinations of input states) are shown in the remaining rows. Figure 5 shows that any single fault fault will be detected by the logic circuitry and therefore actuator device 10 will be disabled.

[0072] In Figure 6, the first column corresponds to no faults, and the remaining columns correspond to the respective 11 single fault conditions in bypass system mode. If the cover 11 is open (see Door1_STATE_GPIO being false in columns e and f) and there is a fault in another signal not related to the cover 11 or the locking device 13 (columns a-d and i-k), the actuator device 10 is disabled. A failure of a signal related to the locking device is bypassed. However, upon returning to normal system mode, this signal failure will be detected and the actuator device 10 will be disabled.

[0073] The logic circuit may be implemented in an electronic (safety) circuit (eg, on a printed circuit board, or PCB).

[0074] In normal system mode, the input logic and electronics are monitored by software that can disable the actuator device 10 and / or the actuator device control unit 17, particularly the actuator device control subunits. For example, two actuator device control subunits / motor control integrated circuits (e.g., a motor controller such as the Trinamic® TMC4361A and a motor driver such as the Trinamic® TMC262) can be disabled to put the actuator device 10 into a safe state. In particular, the TMC4361A motor controller can be disabled via the NFREEZE pin and the TMC262 motor driver can be disabled via the ENN pin.

[0075] The electronic circuitry allows for monitoring of the input states. The cover 11, locking device 13, and bypass signal each have two input states to the electronic circuitry that should always reflect the same state. Such dual redundant states allow for the detection of faults in the electronic circuitry or the wiring of the locking device 13. The state of each redundant input is monitored by both hardware and software, which operate independently.

[0076] If any of the cover status, locking device status, and chiller control unit status indicate that the actuator device 10 should be disabled, the SAFE_STATE_ENGAGED_N signal is activated by the logic circuitry. This signal is connected to the same signals used to control the actuator device 10, namely NFREEZE (STP_ALL_NFREEZE) and ENN (STP_ALL_ENN). In addition to disabling power to the actuator device 10, a brake may be applied to the lift shaft, for example, to prevent the lift shaft from descending when power is disabled.

[0077] The electronic circuitry ensures that no single fault condition will render the IVD laboratory system unsafe or pose a danger to the operator when the cover 11 is open. If the 3.3V power supply is missing, the necessary control signals will not be provided, so the electronic circuitry will not be powered and the actuator device 10 will stop.

[0078] The switching device may be a key switch configured to accept a key for switching and may include, for example, an Eaton® M22-K01 device. The switch has a normally open output and a normally closed output. When the key switch is activated, a 24V signal is provided to the input of the electronic circuit. The normally open and normally closed contacts can be used to detect broken wires.

[0079] The switching device contacts require a minimum current of 5mA. A 4.3kΩ resistor is placed at the input of each switching device. The resistor reduces the current in each contact to I switch Set =U / R=24V / 4.3kΩ=5.6mA. The voltage divider (47kΩ and 7.5kΩ) generates 3.3V at the input of the NC7WZ17.

[0080] Figure 7 shows a diagram of the chiller control circuit. Degradation of the sample in the sample container can occur if the sample temperature exceeds room temperature by, for example, more than 5°C. To ensure proper control of the temperature, the chiller 14, which is equipped with multiple fans, is controlled by a (first) chiller control unit 15 and a second chiller control unit 16, which are implemented in software. The fan speed is controlled by the software in the chiller control unit 15. Because software cannot mitigate the risk, separate hardware (the second chiller control unit 16) is provided to ensure that the fans continue to operate after a software failure. This is achieved via an external monitoring unit 71 and a latch 72.

[0081] The software in the chiller control unit 15 provides a "live" heartbeat signal 73 to a watchdog unit 71, e.g., a watchdog IC, which must be provided at least once every 4.9 seconds. As long as this requirement is met, the software can change the fan speed. In the event of a software failure, the heartbeat signal is no longer sent, and the watchdog unit 71 generates a reset signal / reset pulse 74. The reset signal 74 is sent to the clear input of a latch 72. The heartbeat signal 73 is also connected to the clock input of the latch IC 72. When the (first) chiller control unit 15 is operational, the heartbeat signal 73 generates a high output on the latch 72. In the event of a software failure, the reset pulse 74 from the watchdog unit 71 clears the latch 72, resulting in a low output from the latch 72. The low output transfers control of the fan to more robust hardware (the second chiller control unit 16), which continues to control the fan at full speed until the heartbeat signal 73 reappears. The state of the fan control (chiller control unit state), i.e. hardware or software, is passed to the electronics of the IVD laboratory system.

[0082] The locking device 13 may comprise a safety (inter)lock, such as, for example, an Idec® HS5L-VD7Y4M-G safety lock. The locking device 13 allows for determining whether the cover 11 is open or closed. In particular, the cover position (e.g., door position) may be determined. Furthermore, the state of the solenoid of the locking device 13 may be detected to determine whether the locking device 13 is locked. When the cover 11 is closed and the locking device 13 is locked, the output of the locking device is 24 V. The solenoid locks the cover 11, preventing user access. The user must request access (via an input device) before the locking device 13 can be unlocked. The locking device 13 can be unlocked, for example, upon software request by the user (e.g., to perform preventive maintenance activities). When the locking device 13 is unlocked, the actuator device 10 is instantly disabled.

[0083] Table 2 provides an overview of the different statuses of the locking device 13. Status 2 corresponds to a user access request when the cover 11 (barrier) is in the closed position. In status 4, the locking device 13 is in the locked position but the cover 11 is open.

[0084] [Table 2]

[0085] The features disclosed in the specification, drawings and / or claims may be material for the realization of various embodiments and may be taken alone or in various combinations.

Claims

1. 1. A method for operating an in vitro diagnostic laboratory system (IVD laboratory system), the IVD laboratory system comprising: a housing (12) having an opening (12a); an actuator device (10) arranged in the housing (12) for handling sample containers; a cover (11) configured to cover the opening (12a); a cooling device (14) configured to cool the sample vessel; a cooling device control unit (15) configured to control the operation of said cooling device (14); and the method comprises: Determining whether the cover (11) is open; determining whether the cooling device control unit (15) is operational; In a normal system mode, disabling operation of the actuator device (10) based on at least one of the cover (11) being open and the cooling device control unit (15) not being activated; In a bypass system mode, enabling the operation of the actuator device (10) based on the cover (11) being open and the cooling device control unit (15) being activated. A method comprising:

2. In the normal system mode, enabling operation of the actuator device (10) based on the cover (11) being closed and the cooling device control unit (15) being activated; In the bypass system mode, disabling the operation of the actuator device (10) based on at least one of the cover (11) being closed and the cooling device control unit (15) not being activated. The method of claim 1 further comprising:

3. The IVD laboratory system includes a locking device (13) configured to lock the cover (11), and the method includes: determining whether the locking device (13) is locked; In the normal system mode, disabling the operation of the actuator device (10) further based on the locking device (13) being unlocked.

3. The method of claim 1 or 2, comprising:

4. The method of any one of claims 1 to 3, further comprising switching between the normal system mode and the bypass system mode by user operation of a switching device (19a) of the IVD laboratory system.

5. 5. The method of claim 1, wherein determining whether the refrigerator control unit (15) is operating comprises repeatedly sending a heartbeat signal (73) to a monitoring unit (71) of the IVD laboratory system, and determining that the refrigerator control unit (15) is not operating after a time since the last heartbeat signal was received by the monitoring unit (71) exceeds a timeout threshold.

6. The method of any one of claims 1 to 5, further comprising controlling the cooling device (14) with a second cooling device control unit (16) upon determining that the cooling device control unit (15) is not operating.

7. 7. The method of claim 6, further comprising controlling the cooling device (14) with a variable cooling capacity by the cooling device control unit (15) and controlling the cooling device with a fixed cooling capacity by the second cooling device control unit (16).

8. 8. The method according to claim 6 or 7, wherein the cooling device control unit (15) is implemented in software and the second cooling device control unit (16) is implemented in hardware.

9. 9. The method of claim 1, wherein disabling operation of the actuator device (10) comprises stopping the actuator device (10) upon determining that the actuator device (10) is at least partially moving.

10. The method of any one of claims 1 to 9, wherein disabling the operation of the actuator device (10) comprises interrupting the power supply to the actuator device (10).

11. The method according to any one of the preceding claims, wherein the actuator device (10) comprises at least one of a sample container transport device, a sample container dispensing device, a sample container analysis device, and a motor.

12. 12. The method of claim 1, further comprising disabling operation of the actuator device (10) in the normal system mode further based on at least one of: an actuator device control unit (17) configured to control operation of the actuator device (10) being in a controller reset state; the actuator device control unit (17) being in a controller freeze state; and an emergency user input device (19) being in an actuated state.

13. 13. The method of any one of claims 1 to 12, further comprising determining disabling and enabling operation of the actuator device (10) using a logic circuit that includes a state of the cover, a state of the chiller control unit, and a state of the system mode as logic inputs, and a state of the actuator device as a logic output.

14. The method of claim 13 , wherein the logic circuit is implemented in an electronic circuit using electronic components.

15. 1. An in vitro diagnostic laboratory system (IVD laboratory system), comprising: a housing (12) having an opening (12a); an actuator device (10) arranged in the housing (12) for handling sample containers; a cover (11) configured to cover the opening (12a); a cooling device (14) configured to cool the sample vessel; a cooling device control unit (15) configured to control the operation of said cooling device (14); The IVD laboratory system comprises: Determine whether the cover (11) is open; determining whether the cooling device control unit (15) is operating; In a normal system mode, disabling the operation of the actuator device (10) based on at least one of the cover (11) being open and the cooling device control unit (15) not being activated; In a bypass system mode, the actuator device (10) is enabled to operate based on the cover (11) being open and the cooling device control unit (15) being activated. An IVD laboratory system configured as follows.

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