Device for analyzing biological samples

Abstract

The present invention relates to a method for operating a device for analyzing biological samples, the device comprising: a container for accommodating a replaceable sensor module, the sensor module comprising: one or more sensors and a writable memory; a measuring unit configured to enable the biological sample to interact with at least a first sensor of the one or more sensors of the sensor module accommodated by the container, so as to obtain a measurement result in response to the interaction between at least the first sensor and the biological sample, and output the obtained measurement result; a control unit configured to control the operation of the measuring unit; a data exchange interface configured to receive data from the writable memory and forward the data to the sensor module for storage in the writable memory; and a communication interface for communicating with a remote host system; wherein the method comprises being executed by the control unit: receiving one or more operating parameters associated with the sensor module from the remote host system via the communication interface; causing the received one or more operating parameters to be written to the writable memory via the data exchange interface; and controlling the operation of the measuring unit according to the received one or more operating parameters.

Description

Technical Field

[0001] The present invention relates to aspects of an apparatus for analyzing a biological sample, also referred to hereinafter as an analyzer. In particular, the present invention relates to a body fluid analyzer, such as a blood analyzer. Background Art

[0002] Analyzers for measuring the physical parameters of analytes in biological samples, particularly in liquid samples, by means of corresponding analyte sensors are widely used in various industries, such as in the food industry, environmental industry, and medical and clinical industries. In order to ensure accurate and precise results, the performance of such analyzers and related sensors will be continuously tested. This usually includes detailed calibration and quality control procedures using standardized reference samples, which include corresponding analytes in well-defined components. The accurate and precise operation of the analyzer system is particularly important in clinical analysis applications, which are used to analyze the physical parameters of analytes in body fluids (such as whole blood). In addition to accuracy, precision and reliability requirements, such analyzer systems for clinical applications are also subject to further strict restrictions, such as short time to obtain measurement results, the ability to provide highly reliable results from extremely small sample amounts, and requirements in terms of low operating costs, low downtime, ease of use, etc.

[0003] These limitations are particularly relevant to blood analyzers. Blood analyzers provide measurements of various parameters for analyzing the blood of a mammalian subject, e.g., for establishing and / or monitoring the biological condition of the subject. Typically, the mammalian subject is a human patient. In various cases, it is necessary to measure, for example, the partial pressure of blood gases in a whole blood sample of the mammalian subject, the concentration of electrolytes and metabolites in the blood sample, and the hematocrit value of the blood sample. For example, measurements of pCO2, pO2, pH, Na + , K + , Ca 2+ , Cl - Mg 2+ The values ​​of glucose, lactate, creatinine, urea and hemoglobin and hemoglobin derivatives are the main clinical indications for assessing the patient's condition. There are many different analyzers that perform such measurements for at least some of the above parameters. Such analyzers are capable of performing precise measurements in order to provide the most meaningful diagnostic information.

[0004] The ability to efficiently perform a large number of blood analyses is very important to many healthcare organizations. For example, patients in intensive care require sampling frequencies of 15-20 times per day for blood gas and clinical chemistry measurements, resulting in a potentially large number of blood samples being analyzed each day. Furthermore, in order to limit the number of tests that must be performed, it is desirable to collect as much information as possible after each test is completed. Furthermore, for the same reason, the reliability of the measurements and the corresponding analytical results obtained from these measurements is also important. Therefore, each measurement is typically subject to a calibration and / or quality control procedure using different flushing, calibration and / or reference fluids, and the measurement chamber is thoroughly flushed after each measurement to avoid contamination of any subsequent measurements. Furthermore, the proper and continuous operation of the sensors used to perform the various measurements on the blood samples is critical.

[0005] Since sensors generally have a limited lifespan, known sample analyzers include replaceable sensor modules that include one or more sensors. Thus, an operator of the sample analyzer can remove the currently used sensor module from the sample analyzer and replace it with a new sensor module, thereby being able to continue using the sample analyzer with a new set of sensors.

[0006] Therefore, manufacturers of sample analyzers and sensor modules provide replacement sensor modules. Once manufactured, replacement sensor modules are typically stored for a period of time before being inserted into a sample analyzer for the first time. For example, the replacement modules may be stored at the manufacturer, at various stages of the distribution channel, and / or at a healthcare facility that operates the sample analyzer. Different sample analyzers may require different types of sensor modules, and different sensor modules may be used for different purposes, such as for different numbers of tests, different operating lives, and / or have their own other operating parameters. Therefore, sensor modules for analyzers are typically produced with different variants regarding the number of tests, configuration, lifespan, etc. Therefore, suppliers and customers typically maintain a large inventory of sensor modules to ensure that suitable sensors are always available.

[0007] Furthermore, because different healthcare institutions may require sensor modules to be used with sample analyzers to have different operating parameters, manufacturers and / or distribution channels and / or customers often have to maintain inventory of many different versions of sensor modules, thereby increasing inventory costs and also increasing the risk that some sensor modules may have expired before they are actually put into use.

[0008] It can also feel wasteful if a customer cannot select a sensor module variant that precisely matches a unique customer need. For example, an organization that runs 450 tests per month may be forced to purchase a sensor module that is configured to perform 600 tests and has a lifespan of one month, or to purchase a sensor module that is configured to perform 300 tests. In the first case, the customer would have “wasted” 150 tests; in the second case, the customer might have to spin up an additional sensor. This problem is even more acute when there are spikes or dips in the number of samples analyzed by a given analyzer, as deviations from the norm can make the problem worse.

[0009] Another issue related to replaceable sensor modules relates to possible recalls or customer warnings related to potential quality issues associated with individual sensor modules or batches of sensor modules. When a sensor module manufacturer becomes aware of a quality issue with a portion of the sensor modules it manufactures, a mechanism needs to be provided to prevent further use of those sensor modules.

[0010] Therefore, there is a need to provide a safer, more cost-effective mechanism for operating a sample analyzer. Summary of the invention

[0011] In this context, according to a first aspect, embodiments of a method of operating an apparatus for analyzing a biological sample are disclosed herein, the apparatus comprising:

[0012] a container for accommodating a replaceable sensor module, the sensor module comprising one or more sensors and a writable memory;

[0013] a measurement unit configured to cause the biological sample to operatively interact with at least a first sensor of one or more sensors of the sensor module received by the container, to obtain a measurement result in response to the interaction between the at least first sensor and the biological sample, and to output the obtained measurement result;

[0014] a control unit configured to control the operation of the measurement unit;

[0015] a data exchange interface configured to receive data from the writable memory and forward the data to the sensor module for storage in the writable memory; and

[0016] a communication interface for communicating with a remote host system;

[0017] The method comprises the following steps performed by the control unit:

[0018] a) receiving one or more operating parameters associated with the sensor module from the remote host system via the communication interface;

[0019] b) causing the received one or more operating parameters to be written into the writable memory via the data exchange interface; and

[0020] c) controlling the operation of the measurement unit based on the received one or more operating parameters.

[0021] Therefore, since the operating parameters are received from the remote host system after the container of the device has accommodated the sensor module, the risk of using outdated operating parameters to control the operation of the measuring unit is greatly reduced. This may be particularly important when the operating parameters to be used by a certain sensor module have changed between the time when the sensor module was manufactured and the time when the sensor module was used. For example, experience with a particular type of sensor module may have shown that certain parameter values ​​are more suitable than the parameter values ​​originally specified for the operating parameters. Therefore, embodiments of the methods described herein provide a mechanism that facilitates the use of updated operating parameters. In some cases, it may even be found that a certain type or batch of sensor modules should be recalled rather than used for measurement, or can only be used under certain restrictions. Therefore, the received operating parameters may even indicate such a recall or use restriction of the sensor module. Therefore, a mechanism is provided that increases the reliability of measurement results of a device for analyzing biological samples using a replaceable sensor module.

[0022] Embodiments of the methods disclosed herein further facilitate the implementation of customer-specific and / or device-specific operating parameters associated with different sensor modules without having to manufacture different types of sensor modules and / or stock multiple types of sensor modules. When the sensor module is put into use, the customer-specific and / or device-specific operating parameters can be simply written to the writable memory of the sensor module, that is, there is no need to customize the sensor module before using the sensor module. Examples of such operating parameters include the maximum number of remaining samples that can be analyzed with the sensor module or the longest remaining use time. The sensor module can be manufactured for a sufficiently large maximum number of tests and then configured by the analyzer for a specific number of samples corresponding to the contractual agreement between the supplier and the customer. Therefore, the customer of the analyzer and the sensor module experiences that the sensor module can last exactly as long as the customer needs, thereby reducing waste (discarding unused tests or replacing too many sensor modules). In addition, since the number of required variants of the sensor module to be stocked can be significantly reduced, the demand for inventory is reduced.

[0023] When the received one or more operating parameters are written to the writable memory of the replaceable sensor module, the operating parameters are robustly retrievable under various operating conditions, such as conditions including conditions where the analyzer is offline (i.e., unable to communicate with a remote host system), and / or conditions where the replaceable sensor module is removed from one analyzer and inserted into another, such as an analyzer being temporarily or permanently offline (i.e., unable to communicate with the remote system).

[0024] Thus, embodiments of the methods disclosed herein facilitate methods of operating a device for analyzing a biological sample using a replaceable sensor module that is reliable, safe, robust, and low-cost.

[0025] A device for analyzing a biological sample is also referred to as an analyzer. The analyzer may be an analyzer for measuring a physical parameter of an analyte in a biological sample, such as a body fluid or other liquid biological sample.

[0026] Examples of biological samples can include fluid samples, such as liquid samples and / or gas samples. Liquid samples can be selected from blood, diluted or undiluted whole blood, serum, plasma, saliva, urine, cerebrospinal fluid, pleural, synovial fluid, ascites, peritoneal fluid, amniotic fluid, breast milk, dialysate samples, etc., and any quality control materials and calibration solutions used in analyzer facilities for measuring any of these liquids. Gas samples can include ventilator gases, exhaled gases, etc., and any quality control and calibration materials used in analyzer facilities for measuring any of these fluids. The sample can be processed before testing to make it easier to test. Pretreatment methods can include dilution, filtration, concentration, extraction, removal or inactivation of components that may interfere with the results, and addition of reagents. Examples of other biological samples include fermentation broth or microbial cultures, wastewater, food, etc.

[0027] Furthermore, according to some embodiments, the biological sample is a liquid, such as a body fluid, i.e. a physiological fluid. Accordingly, a sample analyzer for performing the method may be adapted to analyze parameters of a liquid sample, such as a body fluid, i.e. a physiological fluid. Thus, the medical sample analyzer may include a liquid handling system, which includes valves, conduits and / or pumping / transfer tools for controlling the flow of liquid, such as filling and emptying a measurement chamber with a liquid sample, preferably in an automatic manner.

[0028] Furthermore, according to some embodiments, the liquid sample is a liquid sample selected from blood, diluted or undiluted whole blood, serum, plasma, saliva, urine, cerebrospinal fluid, pleural, synovial fluid, ascites, peritoneal fluid, amniotic fluid, breast milk, dialysate samples, etc., as well as any quality control materials and calibration solutions in an analyzer facility for measuring any of these fluids.

[0029] In addition, according to some embodiments, the fluid sample is a gas, such as a medical gas, such as a physiological gas. Accordingly, a sample analyzer using the method is modified to be suitable for analyzing parameters of a medical gas sample. Examples of particularly useful medical gas samples are shown as ventilator gases, exhaled gases, etc., as well as any quality control and calibration materials used in analyzer facilities for measuring any of these fluids. Therefore, the medical sample analyzer may include a gas handling system comprising valves, conduits and / or pumping / transmission tools for controlling gas flow, such as filling and emptying a measurement chamber with the gas sample, preferably in an automatic manner. The medical sample analyzer may even include a fluid handling system suitable for liquids and gases.

[0030] In some embodiments, the analyzer is a blood analyzer configured to provide measurements of various parameters for analyzing the blood of a mammalian subject, e.g., for establishing and / or monitoring the biological condition of the subject. The mammalian subject is typically a human patient. The analyzer can be configured to measure one or more physical parameters of a blood sample, such as the partial pressure of one or more blood gases in a whole blood sample of the mammalian subject, the concentration of one or more electrolytes and / or metabolites in the blood sample, and / or the hematocrit value of the blood sample. For example, the blood analyzer can be configured to measure one or more of the following parameters: pCO2, pO2, pH, Na + , K + , Ca 2 + , Cl - Mg 2+ The values ​​of glucose, lactate, creatinine, urea and hemoglobin and hemoglobin derivatives are also included, as these parameters are important clinical indications for assessing the condition of a medical patient. It should be understood that some embodiments of the analyzer may be configured to measure only one or some of the above parameters, while other embodiments may be configured to measure all of the above parameters. It should also be understood that some embodiments of the analyzer may be configured to measure alternative and / or additional parameters.

[0031] Sensor technologies and sample processing systems suitable for analyzing various types of biological samples are known in the art and will not be described in detail.

[0032] The embodiment of the replaceable sensor module can be a sensor box or other replaceable modules including one or more sensors. In some embodiments, the sensor module includes additional components, such as electronic equipment, vessels with consumables, etc. Some embodiments of the analyzer include two or more separate replaceable modules, such as a sensor box and one or more separate replaceable vessels, which include consumables, such as substances for cleaning the measurement unit, substances for calibrating and / or controlling the quality of the measurement unit, etc. In other embodiments, the sensor module itself may include one or more vessels for accommodating consumables. Therefore, the term sensor module used here is intended to include a sensor box that only includes a sensor but does not include additional consumables, and a combination module that includes a sensor and consumables and / or other additional components. It should also be understood that other types of replaceable sensor modules can also be provided, which are also intended to be included in the term sensor module. The sensor module can be a multi-purpose sensor module that is configured to analyze multiple samples, such as more than 10 samples, such as more than 50 samples, such as more than 100 samples.

[0033] The measuring unit of the device may include any suitable mechanisms and components for enabling the biological sample to interact operationally with at least a first sensor of one or more sensors of the sensor module contained by the container, for obtaining a measurement result in response to the interaction between the at least first sensor and the biological sample, and for outputting the obtained measurement result.

[0034] For example, the measuring unit may include a sample input port for receiving a biological sample from, for example, a sample container, a sample vessel, etc. The measuring unit may include a suitable sample transport mechanism, such as a conduit, a movable component, etc., for enabling the biological sample to interact with at least a first sensor of one or more sensors of the sensor module and / or for subsequently discarding the analyzed sample or for containing the analyzed sample in a waste vessel. To this end, the analyzer may include a suitable fluid handling system, such as described above. Therefore, in some embodiments, the measuring unit is separated from the sensor module. The measuring unit may be configured to receive the biological sample to be analyzed at the sample input port and transport the sample to the sensor module. The measuring unit may also be configured to receive the analyzed sample from the sensor module when the sample is already in operational interaction with at least a first sensor of one or more sensors of the sensor module.

[0035] The measuring unit may also include a suitable signal processing unit for receiving sensor signals from the one or more sensors and for processing the received signals, such as filtering, amplifying, converting signals, etc. The measuring unit may also include a suitable signal analysis unit for analyzing the processed (optionally processed) sensor signals to obtain measurement results. The signal processing and signal analysis units may be separate modules or may be combined into a single module, such as into a single signal and data processing unit. The signal processing unit and / or control unit may be located in the measuring unit or the device.

[0036] The measurement unit may include a user interface, e.g. including a display, a printer, etc., configured to convey operational information to the user, such as the values ​​of received operating parameters, usage limitations represented by the operating parameters, measurement results, error messages, etc. Alternatively or additionally, the device may include another type of output interface, e.g. for transmitting such information to a data processing system, e.g. a healthcare institution information system, via e.g. a computer network.

[0037] The control unit may be fully or partially combined with the signal processing and / or signal analysis unit, or it may be implemented as a separate unit. The control unit may be implemented by a programmable processing unit, including for example one or more microprocessors, or any other suitable circuit or device for controlling the operation of the device.

[0038] The sensor module may include one or more sensors, such as sensors that use different sensing technologies to determine different parameters. The one or more sensors may use any sensing technology suitable for analyzing biological samples. For example, the sensor may be an optical sensor, or it may rely on another form of physical and / or chemical interaction between the sample and the sensor. Example sensors may be configured to determine one or more of various parameters, such as one or more of the following parameters: pO2, pCO2, pH; electrolytes, such as Li + 、Na + , K + , Ca 2+ Mg 2+ , Cl - , HCO 3- or NH3(NH4 + ) concentration; the concentration of metabolic factors, such as glucose, creatinine, urea (BUN), uric acid, lactate, pyruvate, ascorbic acid, phosphate or protein; the concentration of enzymes, such as lactate dehydrogenase, lipase, amylase, choline, esterase, alkaline phosphatase, acid phosphatase, alanine aminotransferase, aspartate, aminotransferase or creatinine kinase.

[0039] The writable memory may store data using any suitable type of storage technology, such as an electrically programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), a writable radio frequency identification (RFID) tag, etc. It should be understood that the choice of storage technology may depend on the amount of data to be written, the number of times the memory is rewritten, and / or other factors, such as unit price, energy consumption, etc. In some embodiments, the writable memory may be a one-time writable memory, while in other embodiments, the memory may be rewritable, i.e., rewritable multiple times. The sensor module may also include memory control logic that is configured to perform write and / or read operations. Therefore, causing the control unit of the analyzer to cause the writing of the operating parameter may include requesting or controlling the memory control logic of the sensor module to perform the write operation. In other embodiments, causing the control unit of the analyzer to write the operating parameter may include performing the write operation by the analyzer itself.

[0040] The data exchange interface can use any suitable data exchange technology, such as data exchange via electrical contact or contactless data exchange. Examples of contactless data exchange include data exchange via capacitive coupling, inductive coupling, near field communication interface, short-range wireless communication interface (e.g., wireless radio frequency communication interface, near infrared communication interface) or any other suitable data exchange technology.

[0041] The container can be any suitable device for operably accommodating the sensor module via, for example, any suitable connector, which can establish a mechanical and / or electrical and / or other operable connection between the sensor module and the measuring unit. The container can define a compartment, which completely or partially closes the sensor module when accommodated by the container. The compartment may include a retaining mechanism and / or a connector for mechanically and / or electrically connecting the sensor module to the device. The compartment may also include a lid, a cover or other mechanisms for closing the compartment. Alternatively, the container can simply provide a connection mechanism, to which the sensor module can be connected without being closed by any surroundings of the container, or the container can provide a partial surrounding, such as a groove or a female connector, which only accommodates the connection portion of the sensor module when accommodated by the container and another part of the sensor module extends outside the container. Therefore, the container can be, or include, a compartment, a groove, a connector such as a female connector or a male connector, a docking mechanism, a slot, a drawer, etc.

[0042] The communication interface for communicating with the remote host system can be a wired or wireless interface, such as a network adapter, a serial port, a USB interface, a parallel port, a WiFi interface, a Bluetooth interface, a LAN connector and / or other suitable interfaces. The device can be connected to the remote host system via a suitable communication network, such as a local area network, the Internet, a computer network, a telecommunications network, etc., or a combination thereof.

[0043] The remote host system may be a suitably programmed and configured data processing system, including one or more computers, virtual machines, etc. The remote host system may be a single central system or a distributed system; it may be suitably programmed to implement an analyzer management system, a customer relationship management system, a product management system, a product maintenance system, etc. In some embodiments, the remote host system includes - or may be communicatively connected to - one or more databases, such as a sensor module database that maintains information associated with a plurality of sensor modules, and / or an analyzer database that maintains information associated with a plurality of analyzers and / or a customer database that maintains information associated with a plurality of customers, such as a customer relationship management system. It should be understood that the remote host system may include one or more databases that allow customer-related information and / or analyzer-related information and / or sensor module-related information to be associated with each other. In some embodiments, the remote host system is operated by a device manufacturer or supplier, such as a manufacturer of an analyzer and / or sensor module. However, in other embodiments, the remote host system is operated by another entity, such as a healthcare institution, a distributor, a supplier, etc.

[0044] In some embodiments, causing the received one or more operating parameters to be written to the writable memory includes causing a timestamp to be written to the writable memory, the timestamp being associated with the one or more operating parameters. Thus, when subsequently retrieving the operating parameters from the memory, the analyzer can determine whether the operating parameters are up to date or whether the analyzer should attempt to receive updated operating parameters from the host system. Thus, the method may include requesting updated operating parameters from the remote host system based on the stored timestamp. If the timestamp is not later than a maximum validity period, the analyzer may even be configured to control the operation of the measurement unit solely based on the one or more operating parameters stored on the writable memory.

[0045] In some embodiments, receiving the one or more operating parameters comprises:

[0046] receiving, via the data exchange interface, a module identifier from the writable memory of a sensor module received by the container;

[0047] transmitting the read module identifier to the remote host system via the communication interface; and

[0048] One or more operating parameters associated with the transmitted module identifier are received from the remote host system via the communication interface.

[0049] Specifically, the host system can notify the analyzer of any changes in operating parameters for a particular sensor module. In addition, the host system can keep a record of when a particular sensor module is used, thereby facilitating inventory management, billing, etc. To this end, transmitting the read module identifier can further include transmitting a timestamp indicating the time when the module identifier was read from the writable memory. Therefore, the time of the first use of the sensor module can be transmitted more accurately, for example, when the analyzer is offline or cannot immediately transmit the module identifier to the remote host system. In this case, the analyzer can cache the information and transmit it to the host system when communication is established next time. The module identifier can be any suitable identifier that identifies the sensor module; it can be a unique identifier that uniquely identifies a particular sensor module, or it can be an identifier that identifies a group of sensor modules, such as a batch of sensor modules manufactured at a specific time, a type of sensor module, etc. In some embodiments, the module identifier is a serial number.

[0050] In some embodiments, receiving the one or more operating parameters comprises:

[0051] transmitting an analyzer identifier to the remote host system via the communication interface, the analyzer identifier identifying a device for analyzing a biological sample;

[0052] One or more operating parameters associated with the transmitted analyzer identifier are received from the remote host system via the communication interface.

[0053] Thus, when operating with the sensor module, the host system can inform the analyzer of the operating parameters to be used by the specific analyzer. For example, the host system can retrieve analyzer-specific information based on the analyzer identifier. Alternatively or additionally, the host system can retrieve information about which customer is operating the identified analyzer and retrieve customer-specific operating parameters, such as customer-specific preferences, customer-specific usage restrictions, etc. Specifically, the method allows suppliers to implement customer-specific billing schemes, in which customers are billed for predetermined usage patterns of sensor modules (e.g., usage time and / or number of samples to be analyzed). The host system can then transmit one or more operating parameters indicating such usage patterns or usage restrictions to the analyzer. The analyzer identifier can be any suitable identifier that identifies the analyzer; it can be a unique identifier that uniquely identifies a specific analyzer, or it can be an identifier that identifies a group of analyzers, such as all analyzers of a specific (part of) organization, a certain type of analyzer, etc. In some embodiments, the analyzer identifier is a serial number. Alternatively or additionally, the remote host system can, for example, maintain the usage history of the analyzer based on log data received from the analyzer. The remote host system can thus determine one or more operating parameters based on the stored usage history. For example, the remote host system can set the maximum remaining number of samples to be analyzed by the sensor module based on typical historical usage patterns. This information can also be used for billing.

[0054] When the operating parameters are written to the memory of the sensor module, the usage mode and / or restrictions of the sensor module can be implemented even if the sensor module is subsequently used with another analyzer. Therefore, the one or more operating parameters associated with the transmitted analyzer identifier may include a usage restriction parameter indicating a usage restriction, which is associated with the sensor module when used with a device identified by the analyzer identifier for analyzing biological samples. Examples of usage restrictions may include limiting the sensor module to be used only with a specific set of one or more analyzers, limiting the maximum remaining number of samples to be analyzed by the sensor module, limiting the maximum remaining time that the sensor module can be used, limiting the type of analysis that the sensor module can perform, etc. In some embodiments, the one or more operating parameters associated with the sensor module include a module expiration parameter indicating the operating life and / or the maximum number of remaining samples associated with the sensor module. Specifically, in some embodiments, controlling the operation of the measurement unit according to the received one or more operating parameters includes preventing the measurement unit from performing further measurements with the current sensor module contained in the container when the operating life or the maximum remaining number of samples associated with the current sensor module contained in the container has been exceeded. Thus, when a sensor module is inserted into the analyzer, the maximum remaining number of samples may be determined by correlating the analyzer with online data regarding historical usage patterns and / or online data regarding contractual agreements between the customer and supplier.

[0055] Receiving the operating parameters from the remote host system and writing these parameters to the writable memory of the sensor module may not need to be performed every time a measurement is performed or even every time the device is started, such as when the power is turned on or started from standby mode. In particular, in some embodiments, the receiving and writing of the operating parameters is only necessary when the sensor module is used for the first time, such as when the sensor module is operably connected to the analyzer for the first time.

[0056] Therefore, in some embodiments, the method may include performing the following steps by the control unit:

[0057] receiving, upon activation of the device, information from a writable memory of a sensor module received by the container via the data exchange interface;

[0058] Based on the received information, determining whether the sensor module has been used before;

[0059] In response to determining that the sensor module has not been previously used, steps a) to c) are performed; otherwise the operation of the measurement unit is controlled according to one or more previously stored operating parameters read from the writable memory via the data exchange interface.

[0060] The information received from the writable memory may, for example, include a timestamp indicating the time of writing the operating parameter and / or a flag indicating whether the parameter has been previously written to the memory and / or the one or more operating parameters themselves. Specifically, when manufacturing the sensor module, such timestamp and / or flag and / or one or more parameter values ​​of the one or more operating parameters may be set to a default value, such as zero or another value that is not a valid timestamp or parameter value, etc., as appropriate. When writing the operating parameter to the writable memory, the analyzer may set the timestamp to the actual write time and / or set the flag and / or set the parameter value to the actual value. Therefore, if the received information shows a default value, the analyzer can determine that the sensor module has not been used previously.

[0061] Optionally, the analyzer may subsequently request updated operating parameters from the remote host system, for example periodically and / or in response to user input or another type of triggering event.

[0062] If, at startup or when triggered to request updated operating parameters, communication to the remote host system cannot be established, then at best the analyzer is operational, even if the device is normally configured to receive (updated) operating parameters. This situation may occur, for example, when the analyzer is offline, for example due to computer network problems or other reasons. If the sensor module has stored thereon previously written operating parameters, the analyzer can of course read these parameters and control the operation of the measurement unit based on these previously written parameters.

[0063] Therefore, in some embodiments, the method comprises the following steps performed by the control unit:

[0064] upon startup of the device, determining whether communication with the remote host system can be established via the communication interface;

[0065] In response to determining that communication with the remote host system can be established, steps a) to c) are performed; otherwise the operation of the measurement unit is controlled according to one or more previously stored operating parameters read from the writable memory via the data exchange interface.

[0066] If communication to the remote host system cannot be established when a new sensor module is used for the first time, in some embodiments, the analyzer may read default operating parameters from a memory of the new sensor module, which have been stored in the memory during manufacture of the sensor module or during subsequent configuration. Alternatively, the analyzer may use a set of default parameters stored in the analyzer's memory. In some embodiments, the analyzer may only allow operation based on such default parameters during a specific time period and / or for a specific number of samples.

[0067] In some embodiments, the method comprises:

[0068] maintaining a local cache of one or more cached operating parameters in a data store of the device;

[0069] In response to determining that the sensor module has not been previously used and cannot establish communication with the remote host system, writing the cached operating parameters to the writable memory via the data exchange interface; and controlling the operation of the measurement unit based on the cached one or more operating parameters.

[0070] Specifically, in some embodiments, in response to determining that communication with the remote host system can be established again, the method includes:

[0071] receiving one or more updated operating parameters associated with the sensor module from the remote host system via the communication interface;

[0072] causing the received one or more updated operating parameters to be written to the writable memory via the data exchange interface; and

[0073] Operation of the measurement unit is controlled based on the received one or more updated operating parameters.

[0074] In some embodiments, steps a) to c) are performed in response to detecting that a new sensor module has been inserted into the container. Alternatively or additionally, in some embodiments, the method comprises performing, by the control unit, the following steps:

[0075] controlling the measurement unit to perform one or more quality control measurements;

[0076] responsive to results of the one or more quality control measurements, obtaining one or more modified operating parameters associated with a sensor module housed by the receptacle;

[0077] causing the one or more modified operating parameters to be written to the writable memory via the data exchange interface; and

[0078] Operation of the measurement unit is controlled according to the one or more modified operating parameters.

[0079] The quality control measurement may be, for example, a measurement performed on one or more predetermined quality control or calibration samples so that the measurement result can be compared with the expected measurement result. Depending on the result of the quality control measurement, the analyzer may modify the operating parameter so that it is used with the particular sensor module and write the modified operating parameter to the writable memory, thereby improving the subsequent measurement performance of the analyzer. Alternatively, the analyzer may transmit the result of the one or more quality control measurements to the remote host system, which may then determine one or more modified operating parameters associated with the sensor module. The analyzer may therefore receive the one or more modified operating parameters from the remote system, so that the received one or more modified operating parameters are written to the writable memory via the data exchange interface; and control the operation of the measurement unit according to the one or more modified operating parameters. Thus, production and / or quality data may be used to determine the operating parameters (e.g., the maximum number of samples to be analyzed), thereby reducing field error rates.

[0080] In some embodiments, the method includes causing the control unit to write usage data such as log data to the writable memory via the data exchange interface in response to the operation of the measurement unit, the usage data indicating one or more usage parameters. Alternatively or additionally, the method may include, in response to the operation of the measurement unit, the control unit transmitting usage data to the remote host system via the communication interface, the usage data indicating one or more usage parameters. Examples of usage data may include log data, such as the number of samples analyzed by the sensor module or the timestamp of the measurement. The usage data may even include measurement results, or a combination of log data and measurement results. Therefore, based on the usage data written in this way, the analyzer and / or the remote host system may, for example, subsequently determine whether a usage limit has been exceeded, may invoke billing, may control inventory management and / or react in different ways. In some embodiments, the remote host system may use the usage data to determine subsequent operating parameters of the sensor module. In some embodiments, the analyzer may record the usage data on the writable memory of the sensor module and periodically, for example, at predetermined time intervals or when the analyzer is online, transmit the recorded usage data to the remote host system.

[0081] In some embodiments, the one or more operating parameters and / or usage data are written to the writable memory in encrypted form. Alternatively, the one or more operating parameters and / or usage data can be written to the writable memory in an encrypted authenticated form. Thus, unauthorized access to the stored data can be prevented and / or it can be ensured that the data has not been tampered with or changed in an unauthorized manner.

[0082] In some embodiments, the one or more operating parameters associated with the sensor module include one or more parameters selected from the group consisting of:

[0083] a lock / unlock flag indicating whether the control unit allows the sensor module to be used to perform measurements;

[0084] one or more feature lock / unlock flags that indicate whether the control unit is to use the sensor module housed by the receptacle to lock or unlock one or more selected features of the device;

[0085] one or more use restriction parameters that restrict use of the sensor module to one or more locations and / or operators and / or healthcare institutions;

[0086] one or more startup parameters indicating a desired startup configuration of a device having the sensor module received by the container; and

[0087] One or more measurement parameters indicative of a desired measurement configuration of a device having the sensor module received by the container.

[0088] The present disclosure relates to different aspects, including the above-mentioned methods, corresponding devices, systems, methods and / or products, each aspect produces one or more benefits and advantages described in combination with one or more other aspects, and each aspect has one or more embodiments corresponding to the embodiments described in combination with one or more other aspects and / or disclosed in the attached claims.

[0089] Specifically, according to one aspect, a device for analyzing a biological sample includes:

[0090] a container for accommodating a replaceable sensor module, the sensor module comprising one or more sensors and a writable memory;

[0091] a measurement unit configured to cause the biological sample to operatively interact with at least a first sensor of one or more sensors of the sensor module received by the container, to obtain a measurement result in response to the interaction between the at least first sensor and the biological sample, and to output the obtained measurement result;

[0092] a control unit configured to control the operation of the measurement unit;

[0093] a data exchange interface configured to receive data from the writable memory and forward the data to the sensor module for storage in the writable memory; and

[0094] a communication interface for communicating with a remote host system;

[0095] The control unit is configured to execute the steps of the method disclosed above and the method disclosed below.

[0096] Generally, here and below, the term control unit is intended to include any circuit and / or device and / or system suitable for performing the functions described herein. Specifically, the above term includes a general-purpose programmable microprocessor or a special-purpose programmable microprocessor, such as a central processing unit (CPU) of a computer or other data processing device or system, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a programmable logic array (PLA), a field programmable gate array (FPGA), a dedicated electronic circuit, etc., or a combination thereof. The control unit can be implemented as a plurality of processing units.

[0097] According to another aspect, a computer program product comprises an executable program code, which is configured to cause the control unit of an apparatus for analyzing a biological sample to perform the steps of the method disclosed above and below when the program code is executed by a control unit. The computer program product may be a computer readable medium, such as a CD-ROM, a DVD, an optical disk, a memory card, a flash memory, a magnetic storage device, a floppy disk, a hard disk, etc. In other embodiments, the computer program product may be a downloadable software package, for example, downloaded on a network server via the Internet or other computer or communication network.

[0098] According to yet another aspect, a system for analyzing a biological sample comprises:

[0099] The device defined here;

[0100] a replaceable sensor module comprising one or more sensors and a writable memory; and

[0101] The remote host system described herein is configured to send one or more operating parameters associated with the sensor module to the device.

[0102] According to yet another aspect, a host system comprises:

[0103] a communication interface for communicating with one or more devices for analyzing a biological sample;

[0104] data processing units; and

[0105] a database including data indicative of one or more customer-specific operating parameters and / or one or more module-specific operating parameters;

[0106] The data processing unit is configured to:

[0107] in response to receiving a module identifier and / or an analyzer identifier from a device for analyzing a biological sample via the communication interface, retrieving the one or more client-specific operating parameters and / or the one or more module-specific operating parameters from the database, and

[0108] The retrieved one or more client-specific operating parameters and / or one or more module-specific operating parameters are forwarded to the device for analyzing a biological sample via the communication interface.

[0109] The host system may be embodied as a data processing system. It may include or be connected to a computer readable medium from which a computer program may be loaded into a processing unit such as a CPU for execution. Therefore, a program code tool may be stored on the computer readable medium, which is suitable for causing the data processing system to perform the steps of the method described herein when executed on the data processing system. The data processing system may include a computer, a system of multiple computers, a virtual machine or another programmable computing device of appropriate programming. The host system may be connected to a suitable communication network, such as the Internet.

[0110] In some embodiments, the data processing unit is further configured to:

[0111] Usage data is received from the device, the usage data indicating one or more usage parameters of the device.

[0112] storing the received usage data in a database; and

[0113] The one or more customer-specific operating parameters and / or the one or more module-specific operating parameters are determined based on the stored usage data.

[0114] According to yet another aspect, a computer program product comprises program code, which, when executed by the data processing unit, is configured to cause a data processing unit of a host system to perform the following steps:

[0115] retrieving one or more client-specific operating parameters and / or one or more module-specific operating parameters from a database associated with the host system in response to retrieving a module identifier and / or an analyzer identifier from a device for analyzing a biological sample via a communication interface of the host system;

[0116] The retrieved one or more client-specific operating parameters and / or one or more module-specific operating parameters are forwarded to the device for analyzing a biological sample via the communication interface.

[0117] As described above, the computer program product according to this aspect may be a computer readable medium, such as a CD-ROM, DVD, optical disk, memory card, flash memory, magnetic storage device, floppy disk, hard disk, etc. In other embodiments, the computer program product may be a downloadable software package, such as downloaded from a network server via the Internet or other computer or communication network. BRIEF DESCRIPTION OF THE DRAWINGS

[0118] Embodiments of various aspects disclosed herein will be described in more detail with reference to the accompanying drawings, in which

[0119] Figure 1 A block diagram of a system including a remote host system and a blood analyzer having a replaceable sensor module;

[0120] Figure 2A Example of memory layout of a writable memory of a replaceable sensor module;

[0121] Figure 2B Another example of a memory layout of a writable memory of a replaceable sensor module;

[0122] Figure 3 a flow chart of an embodiment of a process for operating an analyzer for analyzing a biological sample;

[0123] Figure 4 A data flow diagram of an embodiment of a process for updating operating parameters associated with a replaceable sensor module;

[0124] Figure 5 a flow chart of an embodiment of a process for performing measurements by an analyzer for analyzing a biological sample;

[0125] Figure 6 Flow diagram of an embodiment of a process for performing quality control measurements by an analyzer for analyzing a biological sample. DETAILED DESCRIPTION

[0126] Figure 1A block diagram of a system including a sample analyzer 100, a replaceable sensor module 200, and a remote host system 300 is shown. In this example, the sample analyzer 100 is a blood analyzer. However, it should be understood that in other embodiments, the sample analyzer can be an analyzer for analyzing other types of biological samples. The sample analyzer 100 includes a container 110, such as a sensor box, for accommodating the sensor module 200. In this example, the analyzer includes another container 170 for accommodating a vessel module 400, which includes one or more reservoirs for accommodating consumables (e.g., for rinsing, calibration, and / or quality control purposes) and a waste reservoir. It should be understood that alternative embodiments of the analyzer can operate without the need for any separate vessel module. For example, the sensor module may also include one or more consumables. In yet another alternative embodiment, the analyzer may include a single container for accommodating a sensor module and a vessel module.

[0127] The analyzer includes a sample inlet port 140 for receiving a sample to be analyzed.

[0128] The sensor module 200 includes one or more sensors 211 for analyzing the sample received by the analyzer via the sample inlet port 140. For example, the sensor can be placed in the measurement chamber 210.

[0129] The analyzer 100, the sensor module 200 and the vessel module 400 include a sample handling infrastructure 180 for transporting received samples to interact with the sensor 211, for collecting any consumables from the vessel module 400, and for transporting any waste to the vessel module. The specific details of the sample handling infrastructure may depend on the nature of the sample to be analyzed. For example, for a blood sample or similar liquid sample, the sample handling infrastructure may include a suitable conduit connecting the sample inlet port 140 to the sensor module 200 and a suitable conduit for connecting the sensor module 200 and the vessel module 400, as well as one or more pumps and / or other liquid handling components, such as valves. The conduit may include a suitable conduit coupling mechanism that allows fluid communication to be established between the analyzer and the sensor module and between the analyzer and the vessel module.

[0130] During operation, a sample is transferred through the inlet port 140 to the measurement chamber 210 including the sensor 211. The sensor 211 is arranged to provide substantially simultaneous measurements of analyte parameters in a sample (e.g., a whole blood sample). Preferably, the number of samples required to obtain accurate and reliable data is as small as possible. Detailed examples of sensor assembly designs particularly suitable for simultaneous measurement of multiple different parameters in body fluids (particularly whole blood) and their use in blood analyzers can be found, for example, in European patent EP 2 147 307 B1.

[0131] The analyzer 100 also includes a control unit 120, which includes a signal and data processing unit 121, such as a central processing unit that includes a suitable programming. The control unit is configured to control the operation of the analyzer, including controlling the operation of the sample processing infrastructure. The control unit also receives a sensor signal from the sensor, processes the received sensor signal to calculate a measurement result and outputs the calculated measurement result. To this end, the control unit is operably coupled to a user interface 160. The user interface 160 may include a display and a user input element, such as a physical input element such as a button and / or a virtual input element via a touch screen, etc.

[0132] During operation, based on pre-programmed instructions loaded in the signal and data processing unit 212, and optionally, based on user input, the analyzer uses the sensor 211 to perform measurements on the received sample. The sensor 211 generates a sensor signal representing the physical parameters of each analyte, and provides the sensor signal to the signal and data processing unit 121. The signal and data processing unit 121 is adapted to receive and process the sensor signal from the sensor 211, and present the processed signal as an output to the user, for example, via the user interface 160, and / or forward the output to subsequent / further data analysis. After the measurement, the sample is discharged into the waste reservoir of the vessel unit 400, and the measuring chamber 210 is ready for the next measurement.

[0133] Figure 1The embodiment of the analyzer shown is specially transformed to measure blood parameters.Therefore, performing the measurement, calibration tasks and quality control procedures generally relates to the loading, unloading, flushing, cleaning and reloading of different liquids, which can be completed by the fluid handling infrastructure 180 using the consumables provided in the vessel unit 400.The fluid handling can be controlled in an automatic manner by the control unit 120 according to preprogrammed instructions and / or user input.The vessel module can include a plurality of reservoirs that are pre-equipped with treatment liquids, for flushing / flushing, calibration and quality control tasks.The treatment liquid has a known composition.The treatment liquid of a given treatment step can be selected by a fluid selection valve, and is transferred in the measuring chamber via a supply line.The discharged fluid is finally transported to the waste reservoir of the vessel module 400 by a fluid line.

[0134] At startup and / or in an ongoing manner during normal operation, the analyzer 100 can be configured to perform a self-control routine. If any anomaly is detected, the analyzer 100 indicates the deviation to the user via the user interface 160, and can further indicate the way to overcome the error state. On the other hand, when the analyzer indicates normal operation, the measurement can be performed immediately. Advantageously, according to some embodiments, the self-control routine can be performed during idle time, that is, when the analyzer is in an idle state, in which state the analyzer is not used to perform actual measurements on the user's sample. The self-control routine may include continuous repeated measurements of calibration levels and / or quality control treatment liquids with precisely known components. Then, the signal obtained for each of the different analyte sensors 211 on the known component can be used to continuously update the reference value of the respective analyte measurement and / or modify one or more operating parameters associated with the sensor module currently in use.

[0135] The sensor module 200 is associated with many operating parameters. Specifically, the sensor module can be associated with the maximum remaining number of samples that can be analyzed by the sensor module, such as the maximum number of samples that can be analyzed without excessively reducing the performance of the sensor and / or based on the contractual agreement with the sensor module supplier. In some embodiments, the maximum remaining number of samples can be determined by the contractual relationship between the analyzer supplier and the customer (i.e., the entity using the analyzer, such as a medical institution). For example, the unit price of the sensor module can depend on the maximum number of samples that can be analyzed by the sensor module. Alternatively or additionally, the sensor module can be associated with an operating life (e.g., the maximum remaining time that can be kept working once the sensor module is used). Similarly, the operating life may depend on the characteristics of the sensor and / or the contractual relationship between the supplier and the customer. Alternatively or additionally, the maximum remaining number or operating life of the sample can be determined based on the stored information about the historical usage pattern of the analyzer. To this end, information about the historical usage pattern of the analyzer can be stored by the remote host system.

[0136] Another example of an operating parameter may include the shelf life of the sensor unit, such as the total life span of the sensor unit from the time of manufacture, regardless of whether it has been used. Further operating parameters may include operating parameters of the analyzer used with a particular sensor module, such as the choice of processing fluid, the frequency of flushing and / or calibration, etc.

[0137] The sensor module includes a writable memory 220, for example in the form of a contactless readable and writable memory, such as a writable RFID tag, etc. The memory 220 provides data storage for storing operating parameters associated with the sensor module 200. The memory 220 may also store a module identifier thereon for identifying the sensor module.

[0138] The analyzer includes a data exchange interface 130, such as an RFID reader, which is configured to read data from the memory 220 and write data to the memory 220 when the sensor module is inserted into the container 110 of the analyzer. It should be understood that the memory technology and interface technology used to read from and write to the memory can vary from embodiment to embodiment. Specifically, different wired or contactless data exchange interfaces can be used. The data exchange interface 130 is operably coupled to the control unit 120 to allow the control unit to receive data stored in the memory 220 and send data to the memory 220 for storage.

[0139] The analyzer also includes a communication interface 150, such as a network adapter, for wired and / or wireless communication between the analyzer 100 and a remote host system 300. The communication may be performed via a suitable computer network 500, including, for example, a local area network, the Internet, a telecommunications network, and the like.

[0140] The control unit 120 is configured to exchange data with the remote host system via the communication interface 150 and the computer network 500. Specifically, the control unit can be configured to transmit operational data to the remote host system, such as usage statistics, error messages, analyzer identifiers that identify the analyzer, etc. The control unit can also be configured to transmit data read from the memory 220 of the sensor module 200 to the remote host system, such as module identifiers and / or some or all operating parameters stored on the memory 220. The control unit is also configured to receive information from the remote host system 300, such as operational data to be stored in the memory 220 of the sensor module currently inserted into the analyzer. The data exchange can occur, for example, each time the analyzer is started, each time a new sensor module is inserted, and / or at other times, such as at regular intervals and / or triggered by certain events during the operation of the analyzer. In some embodiments, the analyzer can only operate when it is online, that is, when it can communicate with the remote host system. In other embodiments, the analyzer can also operate offline, that is, the operation of the analyzer when it cannot communicate with the remote host system. This offline operation can be performed over an indefinite period of time or at least over a limited period of time. In such an embodiment, when the analyzer is online again after the offline period, data exchange can be resumed. During the offline period, the analyzer can be configured to maintain local cache data to be transmitted to the remote host system once communication is restored. The cache can be implemented by the memory of the analyzer and / or the memory 220 of the sensor module.

[0141] The remote host system 300 includes a communication interface 310, such as a network adapter, for data communication with the analyzer 100 and optionally with other analyzers that can be connected to the remote host system. The remote host system also includes a processing unit 320, such as a central processing unit of a computer, etc. The remote host system also includes a database 330, such as a product management database and / or a customer relationship management database. It should be understood that the remote host system may include more than one database. The database can also be configured to maintain usage statistics of analyzers running at multiple sites. The remote host system can be implemented by one or more appropriately programmed computers, such as server computers, virtual machines, etc. It should be understood that the processing unit 320, the communication interface 310 and the database 330 can be implemented as a single integrated computer or in a distributed manner, for example, so that the database 330 is implemented by a data processing system different from the data processing system communicating with the analyzer.

[0142] Figure 2A An example of a memory layout of a writable memory of a replaceable sensor module is shown, for example Figure 1 The memory 220 has stored thereon a module identifier 221 that uniquely identifies the particular sensor module. In alternative embodiments, a non-unique identifier may be used, such as an identifier that identifies an entire production batch of sensor modules, a particular type of module, etc. The memory 220 also has stored thereon a plurality of operating parameters 222, such as one or more of the following:

[0143] - the time of initial use of the sensor module;

[0144] - a module expiration parameter indicating an operational lifetime and / or a maximum number of remaining samples associated with the sensor module. The operational lifetime may include an absolute expiration date (e.g. based on the time of production of the module) and / or a relative expiration time relative to the initial time of use of the sensor module. Only if the operational lifetime has not expired is it recommended or even allowed to operate the sensor module. If the operational lifetime defines an absolute lifetime and a relative lifetime, operating the sensor module is recommended or even allowed only if both lifetimes have not expired;

[0145] - a lock / unlock flag indicating whether the control unit allows the use of the sensor module to perform measurements;

[0146] - one or more feature lock / unlock flags that indicate whether the control unit is to lock or unlock one or more selected features of the device using the sensor module housed by the receptacle;

[0147] - one or more usage restriction parameters that restrict usage of the sensor module to one or more locations and / or operators and / or healthcare institutions;

[0148] - one or more startup parameters indicating a desired startup configuration of the device with the sensor module received by the container; and

[0149] - one or more measurement parameters indicating a desired measurement configuration of the device with the sensor module received by the container.

[0150] It should be understood that the module identifier 221 and / or one or more of the operating parameters can be stored in a read-only manner, i.e., such that the analyzer cannot overwrite them. However, at least some of the operating parameters can be written at least once by the analyzer described herein, and optionally can be overwritten several times. In some embodiments, during production, default values ​​for some or all of the operating parameters can be stored. During use of the sensor module, the analyzer can overwrite the default values ​​for some or all of the operating parameters.

[0151] Figure 2B The writable memory of the replaceable sensor module is shown, for example Figure 1 Another example of a memory layout of the memory 220 is shown in FIG. Figure 2A As described, the memory 220 has stored thereon a module identifier (ID) 221. The memory also stores thereon a plurality of operating parameters 223-225. The operating parameters include permanent parameters 223 stored when the sensor module is produced, and these parameters remain unchanged during the life of the sensor module. The operating parameters also include default parameter values ​​224 of a plurality of operating parameters and current values ​​225 of these operating parameters. During manufacturing, the default values ​​are stored in the memory. During the use of the sensor module, the analyzer may store updated versions 225 of these parameters in the memory, but does not overwrite the default values. For this reason, storage areas 221, 223, and 224 may be read-only.

[0152] In some embodiments, some or all of the data stored in the memory may be encrypted, for example so that the analyzer reading the data requires the use of an encryption key to decrypt the data. The encryption key may be an analyzer-specific key for a particular analyzer or a public key for a group of analyzers. Alternatively or additionally, the stored data may be protected by encryption authentication, for example by a digital signature by the entity that has written the data.

[0153] In some embodiments, each operating parameter is associated with a timestamp indicating the time when the respective parameter was stored in the memory.

[0154] It should be understood that the memory 220 may also be configured to store additional data, such as usage statistics and / or other usage data associated with the sensor module. For example, the memory may store thereon a counter indicating the number of samples analyzed by the sensor module.

[0155] Figure 3 A flow chart illustrating an embodiment of a process for operating an analyzer for analyzing a biological sample, such as a Figure 1 Specifically, the process can be executed under the control of the control unit of the analyzer.

[0156] In an initial step S31 , the process determines whether the operating parameters stored in the memory of the sensor module received by the receptacle of the analyser need to be updated and whether the analyser has updated operating parameters available.

[0157] For example, in some embodiments, the operating parameter is updated each time the analyzer is started. Alternatively or additionally, the operating parameter is updated each time a new sensor module is inserted into the container of the analyzer. Alternatively or additionally, the operating parameter is updated each time a quality control measurement is performed. Alternatively or additionally, the operating parameter is updated periodically, such as at regular time intervals. Alternatively or additionally, the operating parameter is updated in response to one or more other triggering events, such as in response to user input, in response to establishing a communication link with a remote host system, in response to a request from a remote system, etc.

[0158] In any case, if the process determines that the operating parameters require updating or the analyzer requires updated operating parameters of the sensor module, the process continues from step S32; otherwise, the process continues from step S36.

[0159] In step S32, the process determines whether communications with the remote host system can be established, e.g. Figure 1 If yes, the process continues at step S33; otherwise, the process continues at step S34.

[0160] At step S33, the process updates the operating parameters stored in the memory of the sensor module. Figure 4 An example of the process of this update is described.The process then continues at step S35.

[0161] At step S34, the process reads currently stored operating parameters from the memory of the sensor module. The currently stored parameters may be, for example, default parameters stored when the sensor module was manufactured, or may be previously stored operating parameters, such as parameters stored by the same analyzer during a previous parameter update process, or if the sensor module has previously been inserted into and used with another analyzer, parameters stored by another analyzer. The process then continues at step S35.

[0162] In step S35, the process verifies the operating parameters obtained in step S33 or step S34. The verification may include one or more verification steps. For example:

[0163] - When the operating parameters include a maximum number of remaining samples, the process may determine the number of samples that have been analyzed with the current sensor module. For example, this number may be obtained from a counter value stored in a memory of the sensor module;

[0164] - when the operating parameters include expiry data, such as an expiry date or a maximum remaining usage period from the time the sensor module was first used, the process may determine whether the expiry date or period has been exceeded;

[0165] - when the operating parameter is protected by authentication, the process may verify that the operating parameter has been written by an authorized source, such as by verifying a digital certificate, optionally based on a request to a remote host system;

[0166] - when the operating parameters include other usage restrictions, such as restrictions for use only with a specific type of analyzer, restrictions for use only with one or more specific analyzers, etc., the process may compare these restrictions with the identifier and / or other authentication information of the current analyzer; and

[0167] - When the operating parameters include a recall flag, the process may determine that the sensor module can no longer be used.

[0168] It should be understood that the verification may include alternative or additional verification steps. In any case, the verification determines whether the analyzer can continue to perform measurements with the currently inserted sensor module, and optionally, whether the analyzer can continue to perform measurements with the currently inserted sensor module only under certain restrictions, such as after an extended warm-up time, an extended exposure time, etc.

[0169] If the verification step determines that it is not possible / advisable to take (further) measurements with the currently inserted sensor module, the process may end with an appropriate error message. Otherwise, the process may continue at step S36, optionally with appropriate indication of any applicable limitations (if any).

[0170] At step S36, the process continues by performing one or more measurements of one or more biological samples.

[0171] Figure 4 A data flow diagram of an embodiment of a process for updating operating parameters associated with a replaceable sensor module is shown. Specifically, Figure 4 Shows Figure 3 A possible implementation of step S33 of the process.

[0172] In initial step S41, the analyzer 100 reads a module identifier from the memory 220 of the sensor module currently inserted into the analyzer. Optionally, the analyzer may further read additional information, such as a timestamp or flag indicating whether the operating parameters stored in the memory have been previously written or updated.

[0173] In step S42, the analyzer 100 transmits the read module identifier (ID) and analyzer identifier to the remote host system 300. The analyzer identifier can uniquely identify a specific analyzer 100, or at least identify a certain type of analyzer.

[0174] In step S43, the remote host system determines one or more operating parameters to be associated with the sensor module currently inserted into the analyzer. To this end, the host system may retrieve the corresponding (one or more) operating parameters from database 330 or several databases.

[0175] For example, based on the module identifier, the remote host system may query a product management database or a production database that stores information about a plurality of sensor modules, such as information associated with individual sensor modules, information associated with a certain production batch of sensor modules, information associated with a certain type of sensor module, etc. For example, if during the time between the manufacture of a sensor module and the use of the module by a customer, it has been shown that certain pre-stored operating parameters should be changed, then these updated parameters may be stored in the database 330 and retrieved by the host system based on the module identifier. In some cases, it may be necessary or desirable to recall certain sensor modules. This may be achieved in an efficient manner by, for example, implementing a recall flag as one of the operating parameters, or by setting the maximum number of remaining samples to be analyzed of the sensor module to zero, or by setting the operating life of the sensor module to zero. The remote host system also stores information about which customer purchased a certain sensor module, and then one or more customer-specific operating parameters may be determined, such as a customer-specific maximum number of remaining samples, a customer-specific operating life, etc. For example, such customer-specific parameters may be based on a contractual agreement between the sensor module supplier and the customer. Such customer-specific parameters may be stored in a product management database or a customer relationship management database.

[0176] Alternatively or additionally, based on the analyzer identifier, the remote host system can query a product management database that stores information about multiple analyzers, such as analyzer-specific usage restrictions or usage restrictions specific to a certain combination of analyzers and sensor modules. The remote host system can also retrieve information about which customer is operating a certain analyzer, and retrieve customer-specific operating parameters, such as customer-specific usage restrictions. To this end, the database may have stored information about which customer purchased the analyzer, including any contractual agreements, billing information, etc. Therefore, the remote host system can determine one or more customer-specific operating parameters, such as a customer-specific maximum number of remaining samples, a customer-specific operating life, etc. For example, such customer-specific parameters can be based on a contractual agreement between the analyzer supplier and the customer. Such customer-specific parameters can be stored in a product management database or a customer relationship management database.

[0177] Alternatively or additionally, the remote host system may retrieve a usage history for the analyzer, such as based on usage data previously received and stored from the analyzer.

[0178] In step S44, the remote host system returns the retrieved operating parameters to the analyzer.

[0179] In a subsequent step S45 , the analyzer writes the received operating parameters into the memory 220 of the sensor module, or at least sends the data to the sensor module for storage in the memory 220 .

[0180] It should be understood that in alternative embodiments, the analyzer may forward only the module identifier or only the analyzer identifier to the remote system. The remote host system may then determine the corresponding operating parameters based only on the module identifier or only on the analyzer identifier. Furthermore, in some embodiments, the analyzer may also forward additional information in addition to the module identifier and / or the analyzer identifier. The remote host system may then also determine the corresponding operating parameters based on such additional information, such as location information about the current location of the analyzer, etc.

[0181] Figure 5 A flow chart showing an embodiment of a process for performing measurements by an analyzer for analyzing a biological sample, such as a Figure 1 Specifically, Figure 5 Can be expressed Figure 3 An embodiment of step S36 of the process is shown.

[0182] In an initial step S51, the process performs the measurement using the obtained operating parameters. The analyzer may display the measurement results on a display of the analyzer, generate a printout of the results, transmit the measurement results to a healthcare institution information system, or the like.

[0183] In step S52, the process writes log information and / or other usage data to the memory of the sensor module currently inserted into the analyzer. Writing the log information may include, for example, updating a counter value stored in the memory, wherein the counter value represents the number of samples analyzed by the sensor module. The log information may include a timestamp of the measurement and / or additional log information.

[0184] If the analyzer is currently online, i.e., able to communicate with the remote host system, the process can optionally continue at step S53 and send log information and / or other usage data to the remote host system, including information written to the memory and / or other log information or usage data, so as to allow the remote host system to maintain a log of the activities of the analyzer and / or the sensor module. In some embodiments, the process can, for example, synchronize the information stored in the memory with the remote log when the analyzer is already offline, i.e., unable to communicate with the remote host system. For example, if the analyzer has stored log information on the memory of the sensor module during the offline period, the process can transmit the current state of the log information stored in the memory of the sensor module. Alternatively or additionally, the analyzer itself can maintain a cache of log information during the offline period, so that when the analyzer is online again, the cached information is transmitted to the remote host system.

[0185] Figure 6 A flow chart illustrating an embodiment of a process for performing quality control measurements by an analyzer for analyzing a biological sample, such as a Figure 1 of this analyzer.

[0186] In step S61, the process performs quality control measurements. For example, the analyzer may periodically perform one or more quality control measurements after analyzing a certain number of samples, in response to user input, upon startup of the analyzer, etc. These measurements may include performing measurements on a known sample (e.g., a quality control liquid) for which the correct measurement result is known. Thus, such measurements allow the analyzer to determine whether the actual measurement result performed on such a quality control sample is within an acceptable deviation range of a known target result.

[0187] In this embodiment, at step S62, the process determines whether one or more of the operating parameters should be modified based on the result of the quality control measurement. The determination can be based on a set of predetermined rules or a more complex algorithm. For example, one of such predetermined rules can define one or more safety margins around a target measurement result for a certain quality control sample. Depending on whether the actual measurement result is within or outside these margins, the process can modify (e.g., increase or decrease) the maximum number of remaining samples associated with the current sensor module. Therefore, the actual operating life of the sensor module can be adjusted in response to the performance of the module in the quality control measurement. To this end, in some embodiments, the determination step can take into account not only the current quality control measurement, but also previous quality control measurements, so as to, for example, determine trends.

[0188] It should be understood that the above determination can be performed by the analyzer and / or the remote host system. In the latter case, the results of the quality control measurement can be transmitted to the remote host system, which can then determine the operating parameters that may have been modified and return the operating parameters modified in this manner to the analyzer. In any case, in some embodiments, the modification requires approval by an authorized operator.

[0189] In a subsequent step S63, the process writes the modified operating parameters into the memory of the sensor module and performs subsequent measurements using the modified operating parameters.

[0190] If the analyzer is currently online, i.e., able to communicate with the remote host system, the process may optionally continue at step S64 and send the modified operating parameters to the remote host system, e.g., as combined with Figure 5 The log information of the process is described.

[0191] Embodiments of the method described herein may be implemented by means of hardware comprising several distinct elements, and / or at least partly by means of a suitably programmed microprocessor.

[0192] In the claims enumerating several means, several of these means may be embodied by one and the same element, component or item of hardware. The mere fact that certain measures are recited in mutually different dependent claims or in different embodiments does not indicate that a combination of these measures cannot be used to advantage.

[0193] It should be emphasized that when used in this specification, the term "includes / comprising" is used to specify the presence of stated features, elements, steps or components, but does not exclude the presence or addition of one or more other features, elements, steps, components or a combination thereof.

Claims

1. A method of operating a device for analyzing a biological sample, the device comprising: a container for accommodating a replaceable sensor module, the sensor module comprising one or more sensors and a writable memory; a measurement unit configured to cause the biological sample to operatively interact with at least a first sensor of one or more sensors of the sensor module received by the container, to obtain a measurement result in response to the interaction between the at least first sensor and the biological sample, and to output the obtained measurement result; a control unit configured to control the operation of the measuring unit; a data exchange interface configured to receive data from the writable memory and forward the data to the sensor module for storage in the writable memory; and a communication interface for communicating with a remote host system; The method comprises the following steps performed by the control unit: a) receiving one or more operating parameters from the remote host system via the communication interface, the one or more operating parameters comprising one or more customer-specific operating parameters and one or more module-specific operating parameters; b) causing the received one or more operating parameters to be written into the writable memory via the data exchange interface; and c) controlling the operation of the measurement unit in dependence on the received one or more operating parameters. 2 . The method of claim 1 , wherein causing the received one or more operating parameters to be written to the writable memory comprises causing a timestamp to be written to the writable memory, the timestamp being associated with the one or more operating parameters.

3. The method according to any of the preceding claims, wherein receiving the one or more operating parameters comprises: receiving, via the data exchange interface, a module identifier from a writable memory of the sensor module received by the container; transmitting the read module identifier to the remote host system via the communication interface; One or more operating parameters associated with the transmitted module identifier are received from the remote host system via the communication interface. 4 . The method of claim 3 , wherein transmitting the read module identifier further comprises transmitting a timestamp indicating a time when the module identifier was read from the writable memory.

5. The method according to claim 1 or 2, wherein receiving the one or more operating parameters comprises: transmitting an analyzer identifier to the remote host system via the communication interface, the analyzer identifier identifying a device for analyzing a biological sample; One or more operating parameters associated with the transmitted analyzer identifier are received from the remote host system via the communication interface.

6. The method according to claim 1 or 2, comprising the following steps performed by the control unit: receiving, when the device is activated, information from the writable memory of the sensor module accommodated by the container via the data exchange interface; determining, based on the received information, whether the sensor module has been previously used; In response to determining that the sensor module has not been previously used, performing steps a) to c); Otherwise the operation of the measuring unit is controlled in dependence on one or more previously stored operating parameters read from the writable memory via the data exchange interface.

7. The method according to claim 1 or 2, comprising the following steps performed by the control unit: upon startup of the device, determining whether communication with the remote host system can be established via the communication interface; In response to determining that communication with the remote host system can be established, steps a) to c) are performed; otherwise the operation of the measurement unit is controlled according to one or more previously stored operating parameters read from the writable memory via the data exchange interface.

8. The method according to claim 1 or 2, comprising the following steps performed by the control unit: controlling the measurement unit to perform one or more quality control measurements; obtaining one or more modified operating parameters associated with the sensor module housed by the container in response to results of the one or more quality control measurements; causing the one or more modified operating parameters to be written to the writable memory via the data exchange interface; and The operation of the measurement unit is controlled according to the one or more modified operating parameters.

9. The method according to claim 1 or 2, comprising causing the control unit to write usage data to the writable memory via the data exchange interface in response to operation of the measuring unit, the usage data being indicative of one or more usage parameters.

10. The method according to claim 1 or 2, wherein the one or more operating parameters associated with the sensor module include one or more parameters selected from the group consisting of: a lock / unlock flag indicating whether the control unit allows the sensor module to perform measurements; one or more feature lock / unlock flags that indicate whether the control unit is to use the sensor module housed by the receptacle to lock or unlock one or more selected features of the device; one or more use restriction parameters that restrict use of the sensor module to one or more locations and / or operators and / or healthcare institutions; one or more startup parameters indicating a desired startup configuration of the device having the sensor module received by the receptacle; One or more measurement parameters indicative of a desired measurement configuration of the device having the sensor module received by the receptacle.

11. The method according to claim 1 or 2, comprising: maintaining a local cache of one or more cached operating parameters in a data store of the device; causing the cached operating parameters to be written to the writable memory via the data exchange interface in response to determining that the sensor module has not been previously used and cannot establish communications with the remote host system; and controlling the operation of the measurement unit based on one or more operating parameters of the buffer.

12. The method according to claim 11, comprising: In response to determining that communications with the remote host system can be reestablished: receiving, via the communication interface, one or more updated operating parameters associated with the sensor module from the remote host system; causing the received one or more updated operating parameters to be written to the writable memory via the data exchange interface; and The operation of the measurement unit is controlled according to the received one or more updated operating parameters.

13. A device for analyzing a biological sample, the device comprising: a container for accommodating a replaceable sensor module, the sensor module comprising one or more sensors and a writable memory; a measurement unit configured to cause the biological sample to operatively interact with at least a first sensor of the one or more sensors of the sensor module received by the container, to obtain a measurement result in response to the interaction between the at least first sensor and the biological sample, and to output the obtained measurement result; a control unit configured to control the operation of the measuring unit; a data exchange interface configured to receive data from the writable memory and forward the data to the sensor module for storage in the writable memory, wherein the data includes data indicative of one or more customer-specific operating parameters and one or more module-specific operating parameters; and a communication interface for communicating with a remote host system; Wherein the control unit is configured to perform the steps of the method defined in any of the preceding claims.

14. A system for analyzing a biological sample, the system comprising: The device as claimed in claim 13; a replaceable sensor module including one or more sensors and a writable memory; and A remote host system is configured to send one or more operating parameters associated with the sensor module to the device.

15. A host system, comprising: a communication interface for communicating with one or more devices for analyzing biological samples as claimed in claim 13; Data processing unit; and a database including data indicative of one or more client-specific operating parameters and one or more module-specific operating parameters; The data processing unit is configured to: in response to a module identifier and / or an analyzer identifier received from a device for analyzing a biological sample via the communication interface, retrieving the one or more client-specific operating parameters and the one or more module-specific operating parameters from the database, and The retrieved one or more client-specific operating parameters and / or one or more module-specific operating parameters are forwarded via the communication interface to the one or more devices for analyzing the biological sample.

16. The host system according to claim 15, wherein the data processing unit is further configured to: receiving usage data from the device, the usage data indicating one or more usage parameters of the device; storing the received usage data in the database; Based on the stored usage data, the one or more customer-specific operating parameters and / or one or more module-specific operating parameters are determined.

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