APPARATUS FOR ANALYZING BIOLOGICAL SAMPLES

Abstract

The present invention relates to a method of operating an apparatus for analyzing biological samples, the apparatus comprising: a receptacle for receiving a replaceable sensor module, the sensor module comprising one or more sensors and a writable memory; a measurement unit configured to bring a biological sample into operational interaction with at least a first sensor of the one or more sensors of a sensor module received by said receptacle, to obtain a measurement result responsive to the interaction between at least the first sensor and the biological sample and to output the obtained measurement result; a control unit configured to control operation of the measurement unit; an data exchange interface configured to receive data from the writable memory and to forward data to the sensor module for storage in the writable memory; and a communications interface for communicating with a remote host system; wherein the method comprises performing the following steps by the control unit: receiving, from the remote host system via said communications interface, one or more operational parameters associated with the sensor module; causing writing, via said data exchange interface, the received one or more operational parameters to the writable memory; and controlling operation of the measurement unit in accordance with the received one or more operational parameters.

Claims

1. A method of operating an apparatus for analyzing biological samples, the apparatus comprising: a receptacle for receiving a replaceable sensor module, the sensor module comprising one or more sensors and a writable memory; a measurement unit configured to bring a biological sample into operational interaction with at least a first sensor of the one or more sensors of a sensor module received by said receptacle, to obtain a measurement result responsive to the interaction between at least the first sensor and the biological sample and to output the obtained measurement result; a control unit configured to control operation of the measurement unit; a data exchange interface configured to receive data from the writable memory and to forward data to the sensor module for storage in the writable memory; and a communications interface for communicating with a remote host system; wherein the method comprises performing the following by the control unit: a) receiving, from the remote host system via said communications interface, one or more operational parameters associated with the sensor module; b) causing writing, via said data exchange interface, the received one or more operational parameters to the writable memory; and c) controlling operation of the measurement unit in accordance with the received one or more operational parameters.

2. The method according to claim 1; wherein causing writing the received one or more operational parameters to the writable memory comprises causing writing a time stamp to the writable memory, the time stamp being associated with the one or more operational parameters.

3. The method according to claim 1; wherein receiving the one or more operational parameters comprises: receiving, via the data exchange interface, a module identifier from the writable memory of the sensor module received by the receptacle; communicating, via the communications interface, the read module identifier to the remote host system; receiving, from the remote host system via the communications interface, one or more operational parameters associated with the communicated module identifier.

4. The method according to claim 3; wherein communicating the read module identifier further comprises communicating a time stamp indicative of a time of reading the module identifier from the writable memory.

5. The method according to claim 1; wherein receiving the one or more operational parameters comprises: communicating, via the communications interface, an analyzer identifier to the remote host system, the analyzer identifier identifying the apparatus for analyzing biological samples; receiving, from the remote host system via the communications interface, one or more operational parameters associated with the communicated analyzer identifier.

6. The method according to claim 1; comprising performing the following by the control unit: upon start-up of the apparatus, receiving information, via the data exchange interface, from the writable memory of a sensor module received by the receptacle; determining, based on the received information, whether or not the sensor module has previously been used; responsive to determining that the sensor module has not previously been used, performing a) through c); otherwise controlling operation of the measurement unit in accordance with one or more previously stored operational parameters read from the writable memory via the data exchange interface.

7. The method according to claim 1; comprising performing the following by the control unit: upon start-up of the apparatus, determining whether or not communication with the remote host system can be established via the communications interface; responsive to determining that communication with the remote host system can be established, performing a) through c); otherwise controlling operation of the measurement unit in accordance with one or more previously stored operational parameters read from the writable memory via the data exchange interface.

8. The method according to claim 1; comprising performing the following by the control unit: controlling the measurement unit to perform one or more quality control measurements; responsive to a result of the one or more quality control measurements, obtaining one or more modified operational parameters associated with the sensor module received by the receptacle; causing writing, via said data exchange interface, the one or more modified operational parameters to the writable memory; and controlling operation of the measurement unit in accordance with the one or more modified operational parameters.

9. The method according to claim 1; comprising causing, by the control unit responsive to operation of the measurement unit, writing usage data to the writable memory via the data exchange interface, the usage data being indicative of one or more usage parameters.

10. The method according to claim 1; wherein the one or more operational parameters associated with the sensor module include one or more parameters chosen from: a lock/unlock flag indicative of whether the control unit is to allow measurements to be performed with the sensor module; one or more feature lock/unlock flags indicative of whether the control unit is to lock or unlock one or more selected features of the apparatus with the sensor module received by the receptacle; one or more usage restriction parameters restricting usage of the sensor module to one or more locations and/or operators and/or health care facilities; one or more start-up parameters indicative of a required start-up configuration of the apparatus with the sensor module received by the receptacle; one or more measurement parameters indicative of a required measurement configuration of the apparatus with the sensor module received by the receptacle.

11. The method according to claim 1; comprising: maintaining, in a data storage of the apparatus, a local cache of one or more cached operational parameters; responsive to determining that the sensor module has not previously been used and that communication with the remote host system cannot be established, causing writing, via said data exchange interface, the cached operational parameters to the writable memory; and controlling operation of the measurement unit in accordance with the cached one or more operational parameters.

12. The method according to claim 11; comprising, responsive to determining that communication with the remote host system can again be established: receiving, from the remote host system via said communications interface, one or more updated operational parameters associated with the sensor module; causing writing, via said data exchange interface, the received one or more updated operational parameters to the writable memory; and controlling operation of the measurement unit in accordance with the received one or more updated operational parameters.

13. An apparatus for analyzing biological samples, the apparatus comprising: a receptacle for receiving a replaceable sensor module, the sensor module comprising one or more sensors and a writable memory; a measurement unit configured to bring a biological sample into operational interaction with at least a first sensor of the one or more sensors of a sensor module received by said receptacle, to obtain a measurement result responsive to the interaction between at least the first sensor and the biological sample and to output the obtained measurement result; a control unit configured to control operation of the measurement unit; a data exchange interface configured to receive data from the writable memory and to forward data to the sensor module for storage in the writable memory; and a communications interface for communicating with a remote host system; wherein the control unit is configured to perform the method of claim 1.

14. A system for analyzing biological samples, the system comprising: the apparatus of claim 13; a replaceable sensor module comprising one or more sensors and a writable memory; and a remote host system configured to send one or more operational parameters associated with the sensor module to the apparatus.

15. A host system comprising: a communications interface for communicating with one or more apparatuses for analyzing biological samples; a data processing unit; and a database comprising data indicative of one or more customer-specific operational parameters and/or of one or more module-specific operational parameters; wherein the data processing unit is configured to: retrieve from the database, responsive to receipt of a module identifier and/or an analyzer identifier from an apparatus for analyzing biological samples via the communications interface, the one or more customer-specific operational parameters and/or the one or more module-specific operational parameters, and to forward the retrieved one or more customer-specific operational parameters and/or the one or more module-specific operational parameters to the apparatus for analyzing biological samples via the communications interface.

16. The host system according to claim 15; wherein the data processing unit is further configured to: receive usage data from the apparatus, the usage data being indicative of one or more usage parameters of the apparatus. store the received usage data in the database; determine the one or more customer-specific operational parameters and/or the one or more module-specific operational parameters based on the stored usage data.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0116] Embodiments of the various aspects disclosed herein will be described in more detail in connection with the appended drawings, which show in

[0117] FIG. 1 a block diagram of a system comprising remote host system and a blood analyzer with a replaceable sensor module;

[0118] FIG. 2A an example of a memory layout of a writable memory of a replaceable sensor module;

[0119] FIG. 2B another example of a memory layout of a writable memory of a replaceable sensor module;

[0120] FIG. 3 a flow diagram of an embodiment of a process for operating an analyzer for analyzing biological samples;

[0121] FIG. 4 a data flow diagram of an embodiment of a process for updating operational parameters associated with a replaceable sensor module;

[0122] FIG. 5 a flow diagram of an embodiment of a process for performing a measurement by an analyzer for analyzing biological samples;

[0123] FIG. 6 a flow diagram of an embodiment of a process for performing a quality-control measurement by an analyzer for analyzing biological samples.

DETAILED DESCRIPTION

[0124] FIG. 1 shows a block diagram of a system comprising sample analyzer 100, a replaceable sensor module 200 and a remote host system 300. In this example, the sample analyzer 100 is a blood analyzer. It will be appreciated though that, in other embodiments, the sample analyzer may be an analyzer for analyzing other types of biological samples. The sample analyzer 100 comprises a receptacle 110 for receiving the sensor module 200, e.g. a sensor cassette. In the present example, the analyzer comprises a further receptacle 170 for receiving a container module 400 including one or more reservoirs accommodating consumables, such as process liquids for rinsing, calibration and/or quality control purposes, and a waste reservoir. It will be appreciated that alternative embodiments of an analyzer may be operable without any need for a separate container module. For example, the sensor module may also include one or more consumables. In yet further alternative embodiments, the analyzer may include a single receptacle for receiving a sensor module as well as a container module.

[0125] The analyzer comprises a sample inlet port 140 for receiving a sample to be analysed.

[0126] The sensor module 200 comprises one or more sensors 211 for analyzing a sample received by the analyzer via the sample inlet port 140. For example, the sensors may be deposited in a measurement chamber 210.

[0127] The analyzer 100, the sensor module 200 and the container module 400 comprise a sample handling infrastructure 180 for conveying a received sample into operational interaction with the sensors 211, for convening any consumables from the container module 400 and for transporting any waste to the container module. The specific details of the sample handling infrastructure may depend on the nature of the samples to be analyzed. For example, in case of blood samples or similar liquid samples, the sample handling infrastructure may comprise suitable conduits connecting the sample inlet port 140 with the sensor module 200 and for connecting the sensor module 200 with the container module 400, as well as one or more pumps and/or other liquid handling components, e.g. valves. The conduits may comprise suitable conduit coupling mechanisms allowing the establishment of fluid communication between the analyzer and the sensor module and between the analyzer and the container module.

[0128] During operation, a sample is transferred through the inlet port 140 to the measurement chamber 210 comprising the sensors 211. The sensors 211 are arranged to provide essentially simultaneous measurements on analyte parameters in a sample, e.g. in a whole blood sample. Preferably, the required sample amount for obtaining precise and reliable data is as small as possible. A detailed example of a sensor assembly design that is particularly suitable for simultaneously measuring a plurality of different parameters in bodily fluids, particularly in whole blood, and its use in a blood analyzer is e.g. found in EP 2 147 307 B1.

[0129] The analyzer 100 further comprises a control unit 120 including a signal and data processing unit 121, e.g. including a suitably programmed central processing unit. The control unit is configured to control operation of the analyzer, including controlling operation of the sample handling infrastructure. The control unit further receives sensor signals from the sensors, processes the received sensor signals to compute measurement results and to output the computed measurement results. To this end, the control unit is operationally coupled to a user interface 160. The user interface 160 may include a display and user input elements, e.g. physical input elements such as buttons and/or virtual input elements implemented via a touch screen or the like.

[0130] During operation, based on pre-programmed instructions loaded in the signal and data processing unit 212 and, optionally, based on user input, the analyzer performs measurements on a received sample using the sensors 211. The sensors 211 generate sensor signals that are representative of a physical parameter for respective analytes and provide the sensor signals to the signal and data processing unit 121. The signal and data processing unit 121 is adapted to receive and process sensor signals from the sensors 211, and to present the processed signals as output to a user, e.g. via user interface 160, and/or forward the output to a subsequent/further data analysis. After measurement, the sample is discharged in a waste reservoir of the container unit 400, and the measurement chamber 210 is prepared for the next measurement.

[0131] The embodiment of the analyzer shown in FIG. 1 is particularly adapted for the measurement of blood parameters. Performing the measurements, calibration tasks, and quality control procedures thus typically involves the loading, unloading, rinsing, cleaning and re-loading of different liquids, which may be done by the fluid handling infrastructure 180 using consumables provided in the container unit 400. The fluid handling may be controlled in an automated way by the control unit 120 according to pre-programmed instructions and/or user input. The container module may include a number of reservoirs pre-filled with process liquids for rinsing/wash-out, calibration and quality control tasks. The process liquids have a known composition. The process liquid for a given process step may be selected by a fluid selector valve and transferred via a feed line into the measurement chamber. The discharged fluids are finally transported through a fluid line to the waste reservoir of the container module 400.

[0132] Upon start-up and/or in an ongoing manner during uptime, the analyzer 100 may be configured to perform self-control routines. If any abnormality is detected, the analyzer 100 indicates the deviation to a user via the user interface 160, and may further indicate ways of overcoming an error state. On the other hand, when the analyzer indicates normal operation, measurements can be performed immediately. Advantageously, according to some embodiments, the self-control routines may be performed during idle times, i.e. when the analyzer is in an idle state, where it is not used for performing actual measurements on a user's sample. The self-control routines may include continued repetitive measurements performed on a calibration-grade and/or quality-control process liquid with a precisely known composition. The signals obtained for each of the different analyte sensors 211on the known composition may then be used to continuously update the reference for the respective analyte measurements and/or to modify one or more operating parameters associated with the currently used sensor module.

[0133] The sensor module 200 has associated with it a number of operational parameters. In particular, the sensor module may have associated with it a maximum remaining number of samples that can be analyzed by the sensor module, e.g. a maximum number of samples that can be analyzed without undue degradation of the sensors and/or based on a contractual agreement with the sensor module vendor. In some embodiments the maximum remaining number of samples may be determined by a contractual relationship between the analyzer supplier and the customer, i.e. the entity using the analyzer, e.g. a healthcare facility. For example, a unit prize of the sensor module may depend on the maximum number of samples that can be analyzed by the sensor module. Alternatively or additionally the sensor module may have an operational lifetime associated with it, e.g. a maximum remaining period of time the sensor module may be kept in operation once it has been taken in use. Again, the operational lifetime may depend on the properties of the sensors and/or on contractual relationship between the supplier and the customer. Alternatively or additionally, the maximum remaining number of samples or the operational lifetime may be determined in dependence of stored information about the historic usage pattern of the analyzer. To this end, information about the historic usage pattern of the analyzer may be stored by the remote host system.

[0134] Another example of an operational parameter may include the shelf life of the sensor unit, e.g. a total lifetime of the sensor unit from the time of its manufacturing, irrespective of whether it has been used or not. Yet further operational parameters may include operational parameters to be used by the analyzer with a particular sensor module, e.g. the selection of process fluids, the frequency of rinsing and/or calibration etc.

[0135] The sensor module comprises a writable memory 220, e.g. in the form of a contactlessly readable and writable memory, e.g. a writable RFID tag or the like. The memory 220 provides a data storage for storing the operational parameters associated with the sensor module 200. The memory 220 may also have a module identifier stored thereon for identifying the sensor module.

[0136] The analyzer comprises a data exchange interface 130, e.g. an RFID reader, configured to read data from the memory 220 and to write data to the memory 220 when the sensor module is inserted in the receptacle 110 of the analyzer. It will be appreciated that the memory technology and the interface technology for reading and writing from/to the memory may vary from embodiment to embodiment. In particular different wired or contactless data exchange interfaces may be used. The data exchange interface 130 is operationally coupled to the control unit 120 so as to allow the control unit to receive data stored in the memory 220 and to send data to the memory 220 for storage.

[0137] The analyzer further comprises a communications interface 150, e.g. a network adapter, for wired and/or wireless communication between the analyzer 100 and remote host system 300. The communication may be performed via a suitable computer network 500, e.g. including a local area network, and internet, a telecommunications network, and/or the like.

[0138] The control unit 120 is configured to exchange data with the remote host system via the communications interface 150 and the computer network 500. In particular, the control unit may be configured to communicate operational data to the remote host system, e.g. including usage statistics, error messages, an analyzer identifier identifying the analyzer, etc. The control unit may further be configured to communicate data read from the memory 220 of the sensor module 200 to the remote host system, e.g. a module identifier and/or some or all of the operational parameters stored on the memory 220. The control unit is further configured to receive information from the remote host system 300, e.g. operational data to be stored in the memory 220 of the sensor module currently inserted in the analyzer. The data exchange may e.g. occur every time the analyzer is started-up, every time a new sensor module is inserted and/or at other times, e.g. at regular intervals and/or triggered by certain events during operation of the analyzer. In some embodiments, the analyzer is only operable when it is on-line, i.e. when communication with the remote host system is possible. In other embodiments, off-line operation of the analyzer is also possible, i.e. operation of the analyzer while it is not able to communicate with the remote host system. Such off-line operation may be possible over indefinite periods of time or at least during a limited period of time. In such embodiments, when the analyzer is on-line again after an off-line period, data exchange may be resumed. During off-line periods, the analyzer may be configured to maintain a local cache of data to be communicated to the remote host system upon resumption of the communication. The cache may be implemented by a memory of the analyzer and/or the memory 220 of the sensor module.

[0139] The remote host system 300 comprises a communications interface 310, e.g. a network adapter, for communicating data with analyzer 100 and, optionally, with other analyzers that are connectable to the remote host system. The remote host system further comprises a processing unit 320, e.g. a central processing unit of a computer, and/or the like. The remote host system further comprises a database 330, e.g. a product management database and/or a customer relationship management database. It will be appreciated that the remote host system may include more than one database. The database may also be configured to maintain usage statistics of analyzers operated at multiple sites. The remote host system may be implemented by one or more suitably programmed computers, e.g. server computers, virtual machines, etc. It will be appreciated that the processing unit 310, the communications interface 310 and the database 330 may be implemented as a single integrated computer or in a distributed fashion, e.g. such that the database 330 is implemented by a data processing system different to the data processing system communicating with the analyzer.

[0140] FIG. 2A illustrates an example of a memory layout of a writable memory of a replaceable sensor module, e.g. of memory 220 of FIG. 1. The memory 220 has stored thereon a module ID 221 which uniquely identifies the particular sensor module. In alternative embodiments, a non-unique identifier may be used, e.g. an identifier that identifies an entire production batch of sensor modules, a particular type of module or the like. The memory 220 has further stored thereon a number of operational parameters 222, such as one or more of the following: [0141] a time of initial use of the sensor module; [0142] a module expiration parameter indicative of an operational lifetime and/or of a maximum remaining number of samples associated with the sensor module. The operational lifetime may include an absolute expiry date (e.g. based on the time of production of the module) and/or a relative expiry time relative to the time of initial use of the sensor module. Operation of the sensor module may only be recommended or even allowed if the operational lifetime has not yet expired. If the operational lifetime defines an absolute lifetime and a relative lifetime, the operation of the sensor module may only be recommended or even allowed as long as both lifetimes have not yet expired. [0143] a lock/unlock flag indicative of whether the control unit is to allow measurements to be performed with the sensor module; [0144] one or more feature lock/unlock flags indicative of whether the control unit is to lock or unlock one or more selected features of the apparatus with the sensor module received by the receptacle; [0145] one or more usage restriction parameters restricting usage of the sensor module to one or more locations and/or operators and/or health care facilities; [0146] one or more start-up parameters indicative of a required start-up configuration of the apparatus with the sensor module received by the receptacle; [0147] one or more measurement parameters indicative of a required measurement configuration of the apparatus with the sensor module received by the receptacle.

[0148] It will be appreciated that the module ID 221 and/or one or more of the operational parameters may be stored in a read-only fashion, i.e. such that an analyzer cannot overwrite them. However, at least some of the operational parameters may be writable at least once and, optionally, re-writable several times, by the analyzer as described herein. In some embodiments, during production, default values for some or all of the operational parameters may be stored. During use of the sensor module, the analyzer may then overwrite the default values of some or all of the operational parameters.

[0149] FIG. 2B illustrates another example of a memory layout of a writable memory of a replaceable sensor module, e.g. of memory 220 of FIG. 1. The memory 220 has stored thereon a module ID 221 as described in connection with FIG. 2A. The memory has further stored thereon a number of operational parameters 223-225. The operational parameters include permanent parameters 223 that are stored at the time of production of the sensor module at that are not changed during the lifetime of the sensor module. The operational parameters further include default parameter values 224 for a number of operational parameters and current values 225 of these operational parameters. At the time of manufacturing, the default values are stored in the memory. During use of the sensor module, the analyzer may store updated versions 225 of these parameters in the memory, but without overwriting the default values. To this end, memory areas 22, 223 and 224 may be read-only.

[0150] In some embodiments, some or all of the data stored in the memory may be cryptographically encrypted, e.g. such that the analyzer reading the data needs to use an encryption key in order to decrypt the data. The encryption key may be analyzer-specific for a particular analyzer, or it may be a common key for a set of analyzers. Alternatively or additionally, the stored data may be cryptographically authenticity protected, e.g. digitally signed by the entity having written the data.

[0151] In some embodiments, each operational parameter is associated with a time stamp indicative of the time of storing the corresponding parameter in the memory.

[0152] It will be appreciated that the memory 220 may further be configured to store additional data, e.g. usage statistics and/or other usage data associated with the sensor module. For example, the memory may have stored thereon a counter indicating the number of samples analyzed by the sensor module.

[0153] FIG. 3 illustrates a flow diagram of an embodiment of a process for operating an analyzer for analyzing biological samples, e.g. the analyzer shown in FIG. 1. In particular, the process may be performed under the control of the control unit of the analyzer.

[0154] In initial step S31, the process determines whether the operational parameters stored in the memory of the sensor module accommodated by the receptacle of the analyzer need to be updated and whether the analyzer has updated operational parameters available.

[0155] For example, in some embodiments, the operational parameters are updated each time the analyzer is started up. Alternatively or additionally, the operational parameters are updated each time a new sensor module is inserted in the receptacle of the analyzer. Alternatively or additionally, the operational parameters are updated each time a quality control measurement is performed. Alternatively or additionally, the operational parameters are updated periodically, e.g. at regular time intervals. Alternatively or additionally, the operational parameters are updated responsive to one or more other trigger events, such as responsive to a user input, responsive to establishment of a communications link with a remote host system, responsive to a request from a remote system and/or the like.

[0156] In any event, if the process determines that the operational parameters require updating or that the analyzer requires updated operational parameters for the sensor module, the process proceeds at step S32; otherwise the process proceeds at step S36.

[0157] At step S32, the process determines whether communication with a remote host system, e.g. host system 300 of FIG. 1, can be established. If this is the case, the process proceeds at step S33; otherwise the process proceeds at step S34.

[0158] At step S33, the process updates the operational parameters stored in the memory of the sensor module. An example of the update process will be described below with reference to FIG. 4. The process then proceeds at step S35.

[0159] At step S34, the process reads the currently stored operational parameters from the memory of the sensor module. The currently stored parameters may e.g. be default parameters stored at the time of manufacturing the sensor module or they may be previously stored operational parameters, e.g. parameters stored by the same analyzer during a previous parameter update process or parameters stored by another analyzer if the sensor module has previously been inserted and used with another analyzer. The process then proceeds at step S35.

[0160] At step S35 the process validates the operational parameters obtained in step S33 or step S34. The validation may include one or more verification steps. For example: [0161] When the operational parameters include a maximum remaining number of samples, the process may determine the number of samples that have already been analyzed with the current sensor module. For example, this number may be obtained from a counter value stored in the memory of the sensor module. [0162] When the operational parameters include expiration data, e.g. an expiration date or a maximum remaining usage period from the time of first use of the sensor module, the process may determine whether the expiration date or period has been exceeded. [0163] When the operational parameters are authenticity protected, the process may verify whether the operational parameters have been written by an authorized source, e.g. by verifying a digital certificate, optionally based on a request to a remote host system. [0164] When the operational parameters include other usage restrictions, e.g. a restriction to be used only with certain types of analyzers, a restriction to be used only with one or more specific analyzers, etc., the process may compare these restrictions with the an identifier of the current analyzer and/or with other validation information. [0165] When the operational parameters include a recall flag, the process may determine that the sensor module may no longer be used.

[0166] It will be appreciated that the validation may include alternative or additional verification steps. In any event, the validation results in a decision as to whether or not the analyzer may proceed to perform measurements with the currently inserted sensor module and, optionally, whether the analyzer may proceed to perform measurements with the currently inserted sensor module only with certain limitations, e.g. after a prolonged warm-up time, with an extended exposure time, and/or the like.

[0167] If the validation steps results in a determination that (further) measurements with the currently inserted sensor module are not possible/advisable, the process may terminate with an appropriate error message. Otherwise the process may proceed at step S36, optionally accompanied with an appropriate indication of any applicable restrictions, if any.

[0168] At step S36, the process proceeds by performing one or more measurements of one or more biological samples.

[0169] FIG. 4 illustrates a data flow diagram of an embodiment of a process for updating operational parameters associated with a replaceable sensor module. In particular, FIG. 4 shows a possible embodiment of step S33 of the process of FIG. 3.

[0170] In initial step S41, the analyzer 100 reads a module identifier from the memory 220 of the sensor module currently inserted in the analyzer. Optionally, the analyzer may further read additional information, e.g. a time stamp or flag indicating whether or not the stored operational parameters in the memory have previously been written or updated.

[0171] In step S42, the analyzer 100 communicates the read module identifier and an analyzer identifier to the remote host system 300. The analyzer identifier may uniquely identify the particular analyzer 100 or at least identify a certain type of analyzer.

[0172] In step S43, the remote host system determines one or more operational parameters to be associated with the sensor module currently inserted into the analyzer. To this end, the host system may retrieve the corresponding operational parameter(s) from a database 330 or several databases.

[0173] For example, based on the module ID, the remote host system may query a product management database or production database that has stored thereon information about a plurality of sensor modules, e.g. information associated with individual sensor modules, information associated with certain production batches of sensor modules, with certain types of sensor modules and/or the like. For example, if during the time between manufacturing a sensor module and the time at which the module is taken in use by a customer, it has turned out that certain pre-stored operational parameters should be changed, these updated parameters may be stored in the database 330 and retrieved by the host system based on a module ID. In some situations, a recall of certain sensor modules may be required or desirable. This may e.g. be implemented in an efficient manner by implementing a recall flag as one of the operational parameters, or by setting a maximum remaining number of samples to be analyzed by a sensor module to zero, or by setting an operational lifetime of a sensor module to zero. The remote host system may also have stored information about which customer has purchased a certain sensor module and may then determine one or more customer-specific operational parameters, e.g. a customer-specific maximum remaining number of samples, a customer-specific operational lifetime etc. For example, such customer-specific parameters may be based on contractual agreements between the sensor module supplier and the customer. Such customer-specific parameters may be stored in a product management database or in a customer relationship management database.

[0174] Alternatively or additionally, based on the analyzer ID, the remote host system may query a product management database that has stored thereon information about a plurality of analyzers, e.g. analyzer-specific usage restrictions or usage restrictions specific for a certain combination of analyzer and sensor module. The remote host system may also retrieve information about which customer is operating a certain analyzer and retrieve customer-specific operational parameters such as customer-specific usage restrictions. To this end, the database may have stored information about which customer has purchased a analyzer, including any contractual agreements, billing information, etc. The remote host system may thus determine one or more customer-specific operational parameters, e.g. a customer-specific maximum remaining number of samples, a customer-specific operational lifetime etc. For example, such customer-specific parameters may be based on contractual agreements between the analyzer supplier and the customer. Such customer-specific parameters may be stored in a product management database or in a customer relationship management database.

[0175] Alternatively or additionally, the remote host system may retrieve a usage history of the analyzer, e.g. based on previously received and stored usage data from said analyzer.

[0176] In step S44, the remote host system returns the retrieved operational parameters to the analyzer.

[0177] In subsequent step S45, the analyzer writes the received operational parameters to the memory 220 of the sensor module or at least sends the data to the sensor module for storage in the memory 220.

[0178] It will be appreciated 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 operational parameters based only on the module identifier or only the analyzer identifier. Yet further, in some embodiments, the analyzer may forward additional information in addition to the module identifier and/or the analyzer identifier. The remote host system may then determine the corresponding operational parameters based also on such additional information, e.g. location information about a current location of the analyzer, etc.

[0179] FIG. 5 illustrates a flow diagram of an embodiment of a process for performing a measurement by an analyzer for analyzing biological samples, e.g. by the analyzer of FIG. 1. In particular, FIG. 5 may represent an embodiment of step S36 of the process of FIG. 3.

[0180] In initial step S51 the process performs the measurement using the obtained operational parameters. The analyzer may display the measurement results on a display of the analyzer, generate a print-out of the results, communicate the measurement results to a health care facility information system, or the like.

[0181] In step S52 the process writes log information and/or other usage data to the memory of the sensor module currently inserted in the analyzer. Writing the log information may e.g. include, updating a counter value stored in the memory where the counter value represents the number of samples analyzed by the sensor module. The log information may include a time stamp of the measurement and/or additional log information.

[0182] If the analyzer is currently online, i.e. is able to communicate with the remote host system, the process may optionally proceed at step S53 and send log information and/or other usage data, including the information written to the memory and/or other log information or usage data, to the remote host system so as to allow the remote host system to maintain a log of the activity of the analyzer and/or the sensor module. In some embodiments, the process may synchronize the information stored in the memory with the remote log, e.g. in situations where the analyzer has been off-line, i.e. has not been able to communicate with the remote host system. For example, if the analyzer, during the off-line period, has stored log information on the memory of the sensor module, the process may communicate a current status of the log information stored in the memory of the sensor module. Alternatively or additionally, the analyzer may itself maintain a cache of log information during off-line periods such that the cached information is transmitted to the remote host system when the analyzer is on-line again.

[0183] FIG. 6 illustrates a flow diagram of an embodiment of a process for performing a quality-control measurement by an analyzer for analyzing biological samples, e.g. by the analyzer of FIG. 1.

[0184] In step S61, the process performs a quality-control measurement. For example, the analyzer may perform one or more quality control measurements periodically, after a certain number of analyzed samples, responsive to a user input, upon start-up of the analyzer, and/or the like. These measurements may involve performing a measurement of a known sample, e.g. a quality control liquid, for which the correct measurement result(s) is/are known. Accordingly, such measurements allow the analyzer to determine whether the actual measurement results performed on such a quality control sample are within acceptable deviations from the known target result.

[0185] In the present embodiment, at step S62, the process determines based on the result of the quality-control measurement whether one or more of the operational parameters should be modified. This determination may be based on a set of predetermined rules or on a more complex algorithm. For example, one of such predetermined rules may define one or more safety margins around a target measurement result for a certain quality control sample. Depending whether the actual measurement results falls within or outside these margins, the process may modify (e.g. increase or reduce) the maximum remaining number of samples associated with the present sensor module. Accordingly, the actual operational lifetime of the sensor module may be adjusted responsive to the module's performance in the quality control measurements. To this end, the determination step may, in some embodiments, not only take the current quality-control measurements into account but also previous quality control measurements, e.g. so as to determine a trend.

[0186] It will be appreciated that the above determination may be performed by the analyzer and/or by the remote host system. In the latter case, the results of the quality control measurements may be communicated to the remote host system which may then perform the determination of possibly modified operational parameters and return the thus modified operational parameters to the analyzer. In any event, in some embodiments the modification may in some embodiments be subject to an approval by an authorized operator.

[0187] In subsequent step S63, the process writes the modified operational parameters to the memory of the sensor module and uses the modified operational parameters for subsequent measurements.

[0188] If the analyzer is currently online, i.e. is able to communicate with the remote host system, the process may optionally proceed at step S64 and send the modified operational parameters to the remote host system, e.g. as described in connection with the log information of the process of FIG. 5.

[0189] Embodiments of the method described herein can be implemented by means of hardware comprising several distinct elements, and/or at least in part by means of a suitably programmed microprocessor.

[0190] In the claims enumerating several means, several of these means can 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 described in different embodiments does not indicate that a combination of these measures cannot be used to advantage.

[0191] It should be emphasized that the term “comprises/comprising” when used in this specification is taken to specify the presence of stated features, elements, steps or components but does not preclude the presence or addition of one or more other features, elements, steps, components or groups thereof.