Method of operating diagnostic equipment

Abstract

Disclosed herein is a computer-implemented method of operating a diagnostic instrument such that a maintenance procedure does not conflict with an operator activity, wherein the maintenance procedure conflicts with an operator activity if a usage probability of the diagnostic instrument is above a usage probability threshold, the usage probability of the diagnostic instrument having been determined based on a detected presence and / or movement of an operator near the diagnostic instrument and / or operation of the diagnostic instrument.

Description

Technical Field

[0001] The present application relates to a computer-implemented method of operating a diagnostic instrument, in particular an in vitro diagnostic instrument. The present application further relates to a diagnostic instrument configured to implement the disclosed method. The present application further relates to a computer program product comprising instructions, which, when executed by a processor of the diagnostic instrument, cause the diagnostic instrument to implement the disclosed method. Background Art

[0002] In vitro diagnostic tests can have a significant impact on clinical decision making, providing physicians with critical information. Diagnostic instruments, especially in vitro diagnostic instruments, perform a variety of analyses on biological samples in order to determine the patient's physiological and biochemical status, which can indicate disease, nutritional habits, drug efficacy, organ function, etc.

[0003] One area of ​​diagnostic testing is performed in laboratories using conventional analytical instruments. These instruments are operated by operators who are trained to maintain and operate such instruments.

[0004] Another area of ​​diagnostic testing is point-of-care or bedside testing. This type of diagnostic testing is performed primarily by nurses or medical personnel who are primarily trained to operate instruments available at the patient care site, such as a hospital, emergency room, intensive care unit, primary care setting, medical center, patient residence, physician's office, pharmacy, or emergency scene.

[0005] Typically, point-of-care testing is required to meet clinical and laboratory requirements for short turnaround times in critical care. Rapid determination of time-critical parameters (e.g., blood glucose, cardiac markers, blood gases, etc.) can speed up decision making in the emergency room, intensive care unit, and even primary care settings. Point-of-care testing has been established worldwide and plays an important role in public health. The potential operational advantages of point-of-care testing include: faster decision making, reduced surgical time, postoperative care time, reduced emergency room time, reduced outpatient visits, reduced number of beds required, and better utilization of professional time.

[0006] Important benefits are achieved when the output of a point-of-care diagnostic instrument is immediately available. Results can be shared instantly with all members of the healthcare team, thereby enhancing communication by reducing turnaround time (TAT).

[0007] However, it has been observed that maintenance and routine activities (such as quality control, calibration, system updates) often impair the availability of point-of-care diagnostic instruments. During such activities, the diagnostic instrument cannot be used to perform diagnostic tests on the patient's biological samples, resulting in increased turnaround time / delayed results. Although efforts have been made to reduce the frequency and / or duration of such maintenance activities, they still have a considerable / significant impact on the availability / readiness of point-of-care diagnostic instruments.

[0008] Therefore, there is a need for a method of operating a point-of-care diagnostic instrument, a diagnostic instrument and a computer program product for a diagnostic instrument, respectively, which improves the usability / readiness of the point-of-care diagnostic instrument for performing diagnostic tests on biological samples of patients. Summary of the invention

[0009] The embodiments disclosed herein are derived from the following observations: although maintenance activities statistically occupy relatively little time of diagnostic instruments, users report that such tasks still have a significant impact on their activities. It has been identified that, in addition to the frequency and duration of the maintenance activities, the timing of maintenance activities also has a significant impact on the perceived availability / readiness of point-of-care diagnostic instruments. For example, if a maintenance activity is performed when a user is actively using or about to actively use the diagnostic instrument, even if the maintenance activity duration is short, the user will perceive that this maintenance activity greatly affects his / her work. On the other hand, despite the objective fact that they spend the same amount of time, performing maintenance activities when the diagnostic instrument is unlikely to be used (e.g., lunch break, night shift) has a lower perceived impact on instrument availability. The embodiments disclosed herein address the need for increased perceived availability of diagnostic instruments by aiming to arrange maintenance activities of diagnostic instruments when the diagnostic instrument is not used or is least likely to be used. Therefore, although the time required for maintenance activities is not affected, the degree of impact of maintenance activities on users is reduced and the perceived availability of diagnostic instruments is therefore increased / improved.

[0010] An embodiment of the disclosed method solves the needs identified above by detecting, by a detection unit, activities in the vicinity of the diagnostic instrument, wherein the activities include the presence and / or movement of an operator in the vicinity of the diagnostic instrument, and / or operations performed on the diagnostic instrument by the operator. The signal of the detection unit is then processed by a processor to determine a probability of use of the diagnostic instrument, wherein the probability of use is proportional to the activities in the vicinity of the diagnostic instrument. The diagnostic instrument then implements a maintenance procedure such as one that does not conflict with the activities, wherein if the probability of use of the diagnostic instrument is above a probability of use threshold, the maintenance procedure conflicts with the activities. If the probability of use of the diagnostic instrument is above the probability of use threshold, implementing a maintenance procedure such as one that does not conflict with the activities includes the diagnostic instrument interrupting and / or postponing the maintenance procedure.

[0011] According to further embodiments disclosed herein, the processor determines an activity pattern based on the signal of the detection unit, the activity pattern indicating a probability of use at (multiple) specific times and / or specific time intervals. The probability of use at (multiple) specific times and / or specific time intervals is proportional to the activity detected at the same time / time interval in the past (e.g., the same hour between the same hours in a day, the same weekday between the same days in a week). In order to ensure that a pre-arranged maintenance process of a longer duration does not reduce the perceived availability of the instrument, the diagnostic instrument then arranges a second type of maintenance process with an expected duration longer than a threshold duration (such as not conflicting with the activity pattern), wherein if the probability of use of the diagnostic instrument is higher than the probability of use threshold at the time scheduled for the implementation of the maintenance process, the maintenance process conflicts with the activity pattern. Therefore, when the diagnostic instrument performs the maintenance process at the scheduled time / time interval, the probability of needing to use the instrument is lower than the set threshold.

[0012] According to further embodiments disclosed herein, a network of multiple diagnostic instruments is communicatively connected to detect activity near the multiple diagnostic instruments. To avoid all instruments performing maintenance procedures and to ensure that at least one instrument is available for analyzing (multiple) patient samples, the maintenance procedures of the multiple diagnostic instruments are scheduled at different times / time intervals to avoid all diagnostic instruments performing maintenance procedures at the same time. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Further features and advantages of the disclosed method / device / system will be described in detail below by describing and referring to the following drawings:

[0014] Figure 1 A flow chart showing a first embodiment of the method disclosed herein;

[0015] Figure 2 A flow chart showing further embodiments of the methods disclosed herein;

[0016] Figure 3 A timeline showing detection of activities, determination of activity patterns, and scheduling of long duration activities and scheduling of activities requiring operator interaction according to embodiments of the methods disclosed herein;

[0017] Figure 4 A timeline illustrating detection of activities and activity patterns specific to a use case in a laboratory environment, wherein presence near an instrument indicates a need to use the instrument, according to an embodiment of the methods disclosed herein;

[0018] Figure 5 A timeline illustrating detection of activities and activity patterns specific to a use case in a patient bedside environment, wherein presence near an instrument does not necessarily indicate a need to use the instrument, according to further embodiments of the methods disclosed herein;

[0019] Figure 6 A timeline showing detection of activities and activity patterns specific to a use case in a physician's office environment, according to further embodiments of the methods disclosed herein, where out-of-range instruments are sometimes used, such as to complete a test that has already been started;

[0020] Figure 7 a timeline showing detection of activity and activity patterns based on day of the week, the timeline showing lower usage on Saturday and no usage on Sunday;

[0021] Figure 8 A timeline showing the staggered arrangement of detection and maintenance of activities and activity patterns on multiple diagnostic instruments;

[0022] Fig. 9 A highly schematic illustration of an embodiment of the disclosed diagnostic instrument;

[0023] Fig.10 A highly schematic block diagram of an embodiment of the disclosed analytical system. DETAILED DESCRIPTION

[0024] Certain terms will be used in this patent application, and the manner in which the terms are expressed should not be construed as limited to the specific terms chosen, but rather as related to the general concept behind the specific terms.

[0025] The terms "sample", "patient sample" and "biological sample" refer to (multiple) materials that may contain an analyte of interest. Patient samples can be obtained from any biological source such as blood, saliva, lens fluid of the eye, cerebrospinal fluid, sweat, urine, feces, semen, milk, ascites, mucus, synovial fluid, peritoneal fluid, amniotic fluid, tissue, cultured cells, etc. Patient samples can be pretreated before use, such as preparing plasma from blood, diluting viscous liquids, dissolving, etc. The processing method may involve filtration, distillation, concentration, inactivation of interfering components and addition of reagents. Patient samples can be used directly after being obtained from the source, or after pretreatment to modify the characteristics of the sample. In some embodiments, the biological material that was originally solid or semi-solid can be made liquid by dissolving or suspending the biological material in a suitable liquid medium. In some embodiments, it is conceivable that the sample contains certain antigens or nucleic acids.

[0026] The term "analyte" is a component of a sample to be analyzed, such as molecules of various sizes, ions, proteins, metabolites, etc. The information collected about the analyte can be used to evaluate the effects of the administration of a drug on an organism or a specific tissue or to perform a diagnosis. Therefore, "analyte" is a general term for information about the presence, absence and / or concentration of a substance. Examples of analytes are, for example, glucose, coagulation parameters, endogenous proteins (e.g., proteins released from the myocardium), metabolites, nucleic acids, ions, gases, etc.

[0027] As used herein, the term "analysis" or "analytical test" encompasses laboratory procedures used to qualitatively assess or quantitatively measure the presence or amount or functional activity of an analyte that characterizes a parameter of a biological sample.

[0028] As used herein, the term "reagent" refers to materials necessary for performing analyte analysis, including reagents for sample preparation, control reagents, reagents for reacting with the analyte to obtain a detectable signal, and / or reagents necessary for detecting the analyte. Such reagents may include reagents for separating analytes and / or reagents for treating samples and / or reagents for reacting with analytes to obtain a detectable signal and / or washing reagents and / or diluents.

[0029] As used herein, the term "kit" refers to any vessel / container containing a liquid reagent or a suspension reagent. Alternatively, a kit is a holder for containing (multiple) containers containing a liquid reagent or a suspension reagent.

[0030] The term "quality control" or "analytical quality control" refers to all those processes and procedures designed to ensure that the results of laboratory analyses (analytical tests) are consistent, comparable, accurate and within specified precision limits.

[0031] As used herein, the term "quality control" QC material refers to any combination of analytes with known concentrations (such as positive controls and negative controls) that are used to provide evidence of successful execution of analytical tests, and to give the sensitivity and specificity of the expected level characterized during technical optimization and validation of analytical tests used for diagnosis. In other words, "quality control" used in the present disclosure refers to a physical sample used to monitor the performance of a specific test or assay of an analyzer during one or more monitoring processes. Positive controls mainly monitor the calibration and sensitivity of the system. Negative controls are mainly used to assess the specificity of analytical tests to identify false positive results.

[0032] As used herein, the term "diagnostic instrument" / "analytical instrument" encompasses any device or device component configured to determine the presence, absence and / or concentration of one or more analytes in the biological sample by performing one or more analytical processing steps on the biological sample. The diagnostic instrument is operable to determine the parameter value of the sample or its components via various chemical, biological, physical, optical or other technical procedures. The diagnostic instrument is operable to measure the parameter of the sample or at least one analyte and return the obtained measured value. The list of possible analysis results returned by the analyzer includes but is not limited to the concentration of the analyte in the sample, the digital (yes or no) result indicating the presence of the analyte in the sample (corresponding to the concentration above the detection level), optical parameters, DNA or RNA sequences, data obtained from the mass spectrometry of proteins or metabolites, and various types of physical parameters or chemical parameters. The diagnostic instrument may include units for assisting pipetting, medication, and mixing samples and / or reagents. The diagnostic instrument may include a reagent holding unit for holding reagents to perform determinations. Reagents may be arranged, for example, in the form of a container or box containing a single reagent or a group of reagents, and placed in a suitable container or position in a storage room or conveyor. It may include a feed unit for consumption. Diagnostic instruments can include processes and detection systems whose workflows are optimized for certain types of analysis. Examples of such diagnostic instruments are clinical chemistry analyzers, coagulation chemistry analyzers, immunochemistry analyzers, urine analyzers, nucleic acid analyzers, which are used to detect the results of chemical or biological reactions or to monitor the progress of chemical or biological reactions.

[0033] As used herein, the term "maintenance process" refers to any activity that needs to be performed on a diagnostic instrument in order to keep the instrument operational within expected parameters, satisfactory regulatory, compliance, and quality specifications. Maintenance processes include, but are not limited to, quality control procedures, calibration processes, instrument refreshes (SW), consumables (such as reagents, quality control materials, or calibration materials) loading, etc.

[0034] As used herein, the term "processor" encompasses any physical or virtual processing device that can be configured to control a laboratory instrument and / or control a system comprising one or more laboratory instruments in the manner of (multiple) workflows and (multiple) workflow steps performed by the laboratory instrument / system. The control unit can, for example, instruct the laboratory instrument / system to perform (multiple) pre-analysis, post-analysis and analysis workflows / (multiple) workflow steps and to implement maintenance procedures. The processor can receive information from the data management unit about which steps need to be performed on a certain sample.

[0035] As used herein, the term "communication network" encompasses any type of wireless network (such as WiFi TM 、GSM TM , UMTS) or other wireless digital networks or cable-based networks such as Ethernet TM ) etc. In particular, the communication network may implement the Internet Protocol (IP). For example, the communication network includes a combination of a cable-based network and a wireless network.

[0036] As used herein, the term "user interface" encompasses any suitable software and / or hardware piece for interaction between an operator and a machine, including but not limited to a graphical user interface for receiving commands as input from an operator and also providing feedback and conveying information to the operator. Also, a system / device may expose multiple user interfaces to serve different categories of users / operators.

[0037] The disclosed method will now be described in more detail.

[0038] A method for operating a diagnostic instrument for analyzing a biological sample is disclosed herein. The diagnostic instrument comprises an analysis unit configured to perform one or more analysis processing steps on the biological sample to determine the presence, absence and / or concentration of one or more analytes in the biological sample.

[0039] Figure 1 A first embodiment of the disclosed method is shown, wherein an instrument performs maintenance activities such as those that do not conflict with currently detected activities around the instrument. Figure 1 As shown above, the receiving, processing and maintenance activities of the biological sample (as a whole) are parallel activities. For example, the start and stop in the flowchart are respectively the start and shutdown of the instrument. Since the step 102 of receiving the biological sample and the processing of the biological sample in step 110 are specific to each instrument but known, these steps will not be described in more detail because the inventive concept disclosed herein can be applied to any type of diagnostic instrument.

[0040] In step 104, human activity is detected near the diagnostic instrument by a detection unit. Activity includes the presence and / or movement of a person near the diagnostic instrument, and / or the operation of the diagnostic instrument by an operator. In this context, proximity should be understood to include anywhere from a few centimeters to a few meters, such as, for example, presence or movement in the same room as the instrument. Thereafter, the signal of the detection unit is processed by the processor of the instrument to determine the probability of use of the diagnostic instrument. The probability of use is calculated as being proportional to the activity near the diagnostic instrument. For example, the probability of use is calculated as a percentage proportional to the level of activity detected. For example, 5 minutes of movement detected in the last 10 minutes is interpreted as a 50% probability of use within a one-minute time interval. For maintenance processes of longer duration, longer time intervals should be considered: for example, if 5 movements are detected in one hour, the probability of use of the instrument is considered to be "high"; if it is 3 times, it is "medium"; and if 1 movement is detected, the probability of use of the instrument is considered to be "low".

[0041] In subsequent step(s) 112, if the diagnostic instrument's usage probability is below the usage probability threshold, the diagnostic instrument implements / performs a maintenance procedure such as one that does not conflict with the activity. In other words, if the diagnostic instrument's usage probability is above the usage probability threshold, the maintenance procedure conflicts with the activity. Continuing with the above example, if the usage probability (based on the detected activity) is below 20% or below "medium," the instrument will initiate / continue the maintenance procedure.

[0042] On the one hand, if the usage probability of the diagnostic instrument is above the usage probability threshold, avoiding conflicts with the detected activity includes the diagnostic instrument interrupting the running maintenance process. Whether the instrument can interrupt the maintenance activity depends on the nature and progress of the corresponding maintenance activity. Usually, interruption is not possible at a later stage to ensure that the instrument remains operational.

[0043] On the other hand, if the usage probability of the diagnostic instrument is above the usage probability threshold, avoiding conflict with the detected activity includes deferring the maintenance process for the diagnostic instrument. The deferral is performed only if the correct operation of the instrument can be ensured (e.g., if the calibration is still valid). The duration of the deferral depends on the expected duration of the maintenance and the urgency of such maintenance.

[0044] Now turn to Figure 2 , further embodiments of the disclosed method will be described, which embodiments incorporate:

[0045] -Perform maintenance procedures so as not to conflict with detected activities;

[0046] as well as

[0047] - Arrange maintenance processes (of the second type - of longer duration) so as not to conflict with the determined activity pattern.

[0048] like Figure 2 As shown above, the processor determines an activity pattern based on the signal of the detection unit in step 106. The activity pattern indicates the probability of use of the instrument not at the present time but at (multiple) specific times and / or specific time intervals.

[0049] According to the embodiments disclosed herein, the determination of activity patterns is an iterative / learning process, and with each activity detected, the activity patterns become more and more accurate. The activity patterns indicate the probability of use of the instrument at a certain minute of the hour, a certain hour of the day, a certain day of the week, etc., according to various usage scenarios.

[0050] In step 108, the diagnostic instrument schedules a second type of maintenance procedure (such as not conflicting with the activity mode) having an expected duration longer than a threshold duration, wherein the maintenance procedure conflicts with the activity mode if the diagnostic instrument usage probability is above the usage probability threshold at the time the maintenance procedure is scheduled to be performed.

[0051] At step 112, the diagnostic instrument performs the scheduled maintenance procedure.

[0052] Such embodiments are particularly advantageous as they allow for faster maintenance activities to be optimally performed as well as longer maintenance activities that can be scheduled in advance.

[0053] Furthermore, according to the embodiments disclosed herein, the step of determining the activity pattern includes one or more of the following steps:

[0054] - detecting activity at predetermined time intervals using a detection unit;

[0055] - Calculate the probability of use in a specific time interval as the average or mean percentage of the activity detected in each time interval;

[0056] - When the usage probability in the vicinity of the diagnostic instrument is above an intensive usage threshold, identifying a time interval and pre-scheduling a maintenance procedure of the diagnostic instrument at a time before the time interval above the intensive usage threshold.

[0057] Intensive use includes, for example, the emergency room or operating room where it is important that maintenance activities do not delay analytical testing, even if this means scheduling some maintenance activities before the maximum interval expires.

[0058] According to further embodiments disclosed herein, the probability of use of the active mode is increased for (multiple) specific times and / or (multiple) time intervals at which instrument operation is detected immediately after a maintenance procedure of the diagnostic instrument is completed, because instrument operation immediately after completion of the maintenance procedure indicates that someone may have to wait for the maintenance procedure to be completed.

[0059] In order to learn and adapt to the details of a particular healthcare environment, according to further embodiments, the step of determining the activity pattern comprises one or more of the following steps:

[0060] - Retrieve the operator's work schedule (from the database)

[0061] The work schedule indicates the time intervals when the operator is on duty and off duty, respectively. In addition, the work schedule may also include planned surgical procedures, time intervals when no maintenance process should prevent the use of the instrument.

[0062] - Determine the correlation between the operator's work schedule and the detected activities

[0063] For example: if a high percentage of operators are off duty, the probability of instrument use will decrease.

[0064] - Extrapolate the activities to the entire work schedule based on the dependencies.

[0065] This is advantageous in case of complete data on the work schedule.

[0066] Since maintenance procedures may have different durations and keep the instrument unavailable for different times, according to embodiments disclosed herein, the method further comprises the step of distinguishing between a first type of maintenance procedure having a first expected duration and a second type of maintenance procedure having a second expected duration, the second duration being longer than the first duration, wherein:

[0067] - if at the time scheduled for the performance of the first type of maintenance procedure, the probability of use of the diagnostic instrument is above a first probability of use threshold, the first type of maintenance procedure conflicts with the activity pattern;

[0068] The second type of maintenance procedure conflicts with the activity pattern if, at the time scheduled for the performance of the second type of maintenance procedure, the diagnostic instrument usage probability is above a second usage probability threshold, the second usage probability threshold being lower than the first usage probability threshold.

[0069] Illustrative Examples:

[0070] In a specific laboratory, the following maintenance activities need to be performed regularly:

[0071] - 1 point instrument calibration

[0072] Duration: 3 minutes

[0073] Frequency: Every hour

[0074] -2-point instrument calibration

[0075] Duration: 7 minutes

[0076] Frequency: Every 12 hours

[0077] - System calibration

[0078] Duration: 15 minutes

[0079] - Frequency: Every 24 hours

[0080] For such an instrument, embodiments disclosed herein:

[0081] - if the diagnostic instrument usage probability based on the currently detected activity is above a usage probability threshold and if the last 1-point calibration was less than 1 hour ago, interrupting and / or postponing the 1-point calibration;

[0082] - scheduling a 2-point calibration at a time within the 12-hour period that does not conflict with "typical" activity based on activity patterns at 1-hour intervals, such as before 12 hours have passed since the last 2-point calibration;

[0083] - Schedule a system calibration at a time within the 24 hour period that does not conflict with "typical" activity, such as based on activity patterns within a 2 hour time interval, before 24 hours have passed since the last system calibration.

[0084] According to further embodiments disclosed herein, the processor categorizes the activity surrounding the instrument according to the following criteria:

[0085] - if the activity involves the operation (actual use) of a diagnostic instrument, it is an activity of group 1;

[0086] - A second group of activities if the detected activity includes presence and / or movement in the vicinity of the diagnostic instrument but does not include operation of the diagnostic instrument.

[0087] The usage probability of the diagnostic instrument corresponding to the first group of activities is set to be higher than the usage probability of the diagnostic instrument corresponding to the second group of activities.

[0088] Figure 3 Examples of determining activity patterns and scheduling long-duration activities and scheduling activities that require operator interaction are shown. Figure 3 As shown, further embodiments of the disclosed method further include: utilizing the probability of the second set of activities being above an operator presence probability threshold, scheduling maintenance procedures requiring operator interaction at specific times(s) and / or specific time intervals.

[0089] Moreover, according to even further embodiments disclosed herein, the processor may further differentiate between movements towards and away from the instrument, respectively, with the probability of use being higher in the first case.

[0090] Now refer to Figures 4 to 6 Describe specific examples for different use cases.

[0091] Figure 4 A timeline of detecting activities and activity patterns specific to a use case in a lab environment is presented, where presence near an instrument indicates a need to use the instrument.

[0092] Figure 5 A timeline is shown for detecting activities and activity patterns specific to a use case in a patient bedside environment, where presence near an instrument does not necessarily indicate a need to use the instrument because the patient is always present. In this use case, the processor only considers the second type of activity when scheduling a maintenance procedure.

[0093] on the other hand, Figure 6 Demonstrated detection of activities and activity patterns specific to a use case in a physician's office environment, where instruments that are out of range are sometimes used, such as to complete a test that has already been started.

[0094] Figure 7 The different granularity of activity patterns based on the day of the week is shown, showing low usage on Saturday and no usage on Sunday.

[0095] According to further embodiments, the processor is configured to determine detectable features that are repeatedly associated with the second set of activities (presence but not use of the instrument). For example, the processor determines that there are people (e.g., cleaning staff) wearing clothes / uniforms of a certain color and / or type around the instrument but never use the instrument. On the other hand, when there are people (e.g., laboratory technicians, nurses) wearing clothes / uniforms of different colors and / or types around the instrument, the processor determines that they often use the instrument.

[0096] The processor then calculates the diagnostic instrument usage probability by ignoring subsequent detections of the second set of activities having such characteristics associated with the second set of activities being repeated. This ensures that the laboratory instrument can perform maintenance activities at times / intervals when there is activity around the instrument but the activity (most likely) does not require the instrument to be used.

[0097] Furthermore, facial features of the person associated with the detected activity (eg, a face ID) may also be used, for example in conjunction with a database including facial features of persons who are active users of the laboratory instrument.

[0098] Machine learning techniques may also be used in order to continuously improve the determination of the exact characteristics and the determination of the probability of correct use of the instrument, respectively, based on the processing of the signals of the detection unit.

[0099] Now go to Figure 8, detection of activities and activity patterns on multiple diagnostic instruments and staggered scheduling of maintenance will be described. To optimize a healthcare environment with multiple instruments, activities near multiple diagnostic instruments are detected, and a central control unit is employed to determine activity patterns by processing the detected activities with respect to the multiple diagnostic instruments. To prevent a situation where no diagnostic instruments are available for patient testing, the central control unit schedules maintenance procedures for the multiple diagnostic instruments to avoid all instruments performing maintenance procedures at the same time.

[0100] In order to avoid applying a wrong activity pattern, according to a further embodiment disclosed herein, the instrument is configured such that the activity pattern is reset when the instrument is repositioned.

[0101] Fig. 9 A highly schematic illustration of an embodiment of the disclosed diagnostic instrument 1 for analyzing a biological sample is shown. The diagnostic instrument 1 comprises an analysis unit (12) configured to perform one or more analytical processing steps on the biological sample to determine the presence, absence and / or concentration of one or more analytes in the biological sample. In addition, the diagnostic instrument 1 comprises or is connected to a detection unit (14) configured to detect the presence, movement and / or activity in the vicinity of the diagnostic instrument (1). The diagnostic instrument 1 also comprises or is connected to a control unit (16) configured to implement any method disclosed herein.

[0102] According to the embodiments disclosed herein, the detection unit (14) comprises one or more of the following:

[0103] - Motion sensor;

[0104] - Proximity sensors (such as RADAR or LIDAR);

[0105] - Image / video capture devices + image analysis;

[0106] - Light intensity sensor;

[0107] -microphone;

[0108] -Connection to the instrument's user interface.

[0109] Fig.10An analysis system 50 is shown that includes a plurality of diagnostic instruments 1.1 to 1.n for analyzing a biological sample, each diagnostic instrument 1.1 to 1.n including an analysis unit 12, which is configured to perform one or more analytical processing steps on the biological sample to determine the presence, absence and / or concentration of one or more analytes in the biological sample. The analysis system 50 further includes one or more detection units 14, which are configured to detect the presence, movement and / or activity of an operator in the vicinity of the plurality of diagnostic instruments 1.1 to 1.n. ​​A central control unit 60 is communicatively connected to the plurality of diagnostic instruments 1.1 to 1.n and the one or more detection units 14, and the control unit 60 is configured to implement any method disclosed herein.

[0110] The present disclosure further relates to a computer program product comprising instructions which, when executed by a processor of a diagnostic instrument, cause the diagnostic instrument to perform the steps according to any method disclosed herein.

[0111] The present disclosure further relates to a computer program product comprising instructions which, when executed by a central control unit of an analysis system comprising a plurality of diagnostic instruments for analyzing biological samples, cause the analysis system to perform the steps according to any of the methods disclosed herein.

[0112] As used herein, a computer program product refers to a program that is a tradable product. The product may generally exist on a computer-readable data carrier, locally or in a remote location (cloud), in any format such as a downloadable file. In particular, the computer program product may be distributed over a data network such as a cloud environment. Furthermore, not only the computer program product, but also the execution hardware may be located locally or in a cloud environment.

[0113] List of reference numerals:

[0114] Diagnostic instruments 1

[0115] Analysis Unit 12

[0116] Detection unit 14

[0117] Processor 16 (of the instrument)

[0118] Analysis system 50

[0119] Central control unit 60

[0120] Receive and identify samples step 102

[0121] Detection Activity Step 104

[0122] Determine the probability of use step 105

[0123] Determine the activity mode step 106

[0124] Schedule Maintenance Step 108

[0125] Process the sample step 110 via the target instrument

[0126] Perform maintenance step 112

Claims

1. A method of operating a diagnostic instrument (1) for analyzing a biological sample, the diagnostic instrument comprising an analysis unit (12) configured to perform one or more analytical processing steps on the biological sample to determine the presence, absence, and / or concentration of one or more analytes in the biological sample, The method comprises: - Detecting, by a detection unit (14), activities in the vicinity of the diagnostic instrument (1), wherein the activities include the presence and / or movement of an operator in the vicinity of the diagnostic instrument (1) and / or operations performed on the diagnostic instrument (1) by the operator; - Processing, by a processor (16), the signals of the detection unit (14) to determine the probability of use of the diagnostic instrument (1), the probability of use being proportional to the activities in the vicinity of the diagnostic instrument (1); - The diagnostic instrument (1) performing a maintenance process that does not conflict with the activities, wherein if the probability of use of the diagnostic instrument (1) is higher than a use probability threshold, the maintenance process conflicts with the activities, The method further comprises: - The processor (16) determining an activity pattern based on the signals of the detection unit (14), the activity pattern indicating the probability of use at one or more specific times and / or within a specific time interval; - The processor (16) classifying the activities around the instrument according to the following criteria: - As a first group of activities if the activities include the operation of the diagnostic instrument (1); - As a second group of activities if the detected activities include the presence and / or movement in the vicinity of the diagnostic instrument (1) but do not include the operation of the diagnostic instrument (1), - wherein the probability of use of the diagnostic instrument (1) corresponding to the first group of activities is set higher than the probability of use of the diagnostic instrument (1) corresponding to the second group of activities; - The diagnostic instrument (1) scheduling a second type of maintenance process having an expected duration longer than a threshold duration such that at the time when the maintenance process is scheduled to be implemented, the probability of use of the diagnostic instrument (1) is lower than the use probability threshold; - The diagnostic instrument (1) performing the maintenance process as scheduled.

2. The method according to claim 1, further comprising: If the probability of use of the diagnostic instrument (1) is higher than the use probability threshold, the diagnostic instrument interrupts and / or postpones the maintenance process.

3. The method according to claim 1, further comprising: - The processor (16) determining detectable features associated with the repetition of the second group of activities; - Setting the probability of use of the diagnostic instrument (1) while ignoring subsequent detections of the second group of activities having such features associated with the repetition of the second group of activities.

4. The method according to claim 3, wherein, such features include: - A specific color and / or type of clothing of a person associated with the detected activities.

5. The method according to claim 3, wherein, such features include: - A specific color and / or type of uniform of a person associated with the detected activities.

6. The method according to claim 3, in, Such characteristics include: - Facial features of the person associated with the detected activity.

7. The method according to claim 1, further comprising: The following steps are involved: A maintenance procedure requiring operator interaction is scheduled at one or more specific times and / or within a specific time interval, wherein the probability of the second set of activities is above an operator presence probability threshold.

8. The method according to claim 1, in, The step of determining the activity mode may include one or more of the following steps: - detecting activity at predetermined time intervals using the detection unit (14); - Calculate the probability of use in a specific time interval as the average percentage of activity detected in each time interval; - identifying a time interval when the usage probability near the diagnostic device (1) is above an intensive usage threshold, and pre-scheduling a maintenance procedure of the diagnostic device (1) at a time before the time interval above the intensive usage threshold.

9. The method according to claim 1, in, The usage probability of the active mode increases for one or more specific times and / or one or more time intervals during which instrument operation is detected immediately after a maintenance procedure of the diagnostic instrument is completed.

10. The method according to claim 1, in, The step of determining the activity mode may include one or more of the following steps: - Retrieve operator work schedule from database; - determining a correlation between said operator work schedule and the detected activities; - Extrapolate activities to the entire work schedule based on the stated dependencies.

11. The method according to claim 1, further comprising: The following steps are involved: - distinguishing between a maintenance procedure of a first maintenance procedure type having a first expected duration and a maintenance procedure of a second maintenance procedure type having a second expected duration, the second expected duration being longer than the first expected duration; - the diagnostic instrument (1) schedules a maintenance procedure of a first type so that, at the time scheduled for performing the maintenance procedure of the first type, the probability of use of the diagnostic instrument (1) is below a first probability of use threshold; - the diagnostic instrument (1) schedules a maintenance procedure of the second type so that, at the time scheduled for carrying out the maintenance procedure of the second type, the probability of use of the diagnostic instrument (1) is below a second probability of use threshold value, The second usage probability threshold is lower than the first usage probability threshold.

12. The method according to claim 1, further comprising: The following steps are involved: - Detect activity near multiple diagnostic instruments; - a central control unit (60) determines an activity pattern by processing the activities detected by the plurality of diagnostic instruments; - The central control unit (60) schedules the maintenance procedures of the plurality of diagnostic instruments to avoid all diagnostic instruments performing maintenance procedures at the same time.

13. A diagnostic instrument (1) for analyzing a biological sample, the diagnostic instrument include: - an analysis unit (12) configured to perform one or more analytical processing steps on the biological sample to determine the presence, absence and / or concentration of one or more analytes in the biological sample; - a detection unit (14) configured to detect presence, movement and / or activity in the vicinity of the diagnostic instrument (1); - A processor (16) configured to implement the method of any one of claims 1 to 12.

14. The diagnostic instrument (1) according to claim 13, in, The detection unit (14) includes one or more of the following: - Motion sensor; - Proximity sensor; - Image / video capture devices + image analysis; - Light intensity sensor; - microphone; - connection to a user interface of the diagnostic instrument (1).

15. A computer program product comprising instructions which, when executed by a processor (16) of a diagnostic instrument (1), cause the diagnostic instrument (1) to perform the steps of the method according to any one of claims 1 to 12.

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