MXPA01005413A - Analyte test instrument having improved calibration and communication processes - Google Patents

Abstract

An analyte test instrument having improved calibration and communication processes. The instrument employs a calibration method that allows it to communicate with any one of a plurality of data storage strips. A data storage strip including a memory device is inserted into the test port of the instrument. The data storage strip is identified, and the instrument establishes communications with the data storage strip using a protocol corresponding to the data storage strip. Second, the instrument employs a method for ensuring that the instrument is operated using valid calibration strips and test strips. The instrument determines whether one or more of test parameters stored in the instrument is invalid for a test strip inserted into the test port of the instrument. If a test parameter is invalid, an indication of the invalid strip parameter is displayed on the display. Finally, the instrument utilizes a method for determining the actual date and time of events that occurred before the instrument was provided with current date and time.

Description

INSTRUMENT FOR ANALYTICAL TESTS THAT HAS CALIBRATION AND COMMUNICATION PROCESSES MEJO RADOS This application claims the priority of Provisional Application No. 60 / 110,227, filed on November 30, 1998.

CROSS REFERENCE WITH RELATIVE REQUESTS This application is a co-pending application for an application submitted on the same date as this, which has a file number 6622. US.01, and entitled "Device and Test Strips for Multiple Chemistry Measurement" (hereinafter "Multiple Chemistry Application"), the content of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to instruments for testing analytes that perform electrochemical assays in biological samples. More particularly, the invention relates to analyte testing instruments that have improved calibration and communication processes. 2. Discussion of the Technique An analyte test instrument can be used to perform electrochemical assays (eg, gucose concentration) in biological samples (eg, blood). To operate such an instrument, a user inserts a test strip into a test hole in the instrument. The instrument shows a "ready" indication to the user and expects the user to deposit a biological sample on the test strip. When a sufficient amount of material has been deposited in the reaction area of the test strip, an electrochemical reaction occurs. The electrochemical reaction causes a flow of electrons, which produces an electrical signal, such as a change in current, that an instrument can detect. The instrument converts the detected signal into information that corresponds to analyte information and displays the information to the user. The instrument may have the ability to store a plurality of such measurements and provide this information to the user via a display or external processor via an information link. Instruments for testing analytes for electrochemical tests often require the user to calibrate the instrument periodically. A known calibration technique is described in the U.S. Patent. , No. 5,366,609 to White et al. The instrument described requires a read-only-memory key (ROM) removably inserted for operation and calibration of the instrument. The ROM key is inserted into a hole, which is different from the test hole, and must remain in the instrument during the operation and calibration test. A test strip is inserted into the test hole after the ROM key is inserted into the ROM key hole. The ROM key contains constants and lot-specific data required to carry out analyte determination procedures on biological material applied to the test strips. In addition, the ROM key may contain some or all of the codes that control the test. A microprocessor in the instrument uses the constants, conversion factors and codes provided by the ROM key in a "base as needed" to perform the tests. Another calibration technique is employed by the blood glucose test system PREC I S ION Q. I. D manufactured and sold by MEDISENSE, Inc. Bedford Massachusetts. The instrument has a single hole that receives separately both calibration strips and test strips. A calibration strip that includes specific data and constants for a given batch of test strips, including the batch code for the test strips, is provided with each batch of test strips. Typically, when a new box of test strips is opened, the user first inserts the calibration strip into the test hole to calibrate the instrument. The user then removes the calibration strip, and the instrument is ready to receive test strips. The instrument stores the batch code for the calibration strip and shows that code to the user. Thus, the user can manually verify that the batch code matches the code printed on each test strip to be used. The calibration data for the instrument are Specific to test strips that have the same batch code and remain stored in the instrument until another calibration strip is inserted. Although manufacturers of analyte test instruments take great care to provide accurate calibration devices and detailed instructions on the calibration process, errors attributable to the calibration process often contribute to erroneous test readings. For example, known instruments do not alert the user to avoid running a test without a test strip that does not equal the calibration of the instrument or with a test strip that has expired. Furthermore, the known instruments do not have the capacity to perform a multiplicity of different tests with a single measuring device having a broad spectrum to test functionalities without having to manually reconfigure the instrument.

BRIEF DESCRIPTION OF THE INVENTION The present invention provides an analyte test instrument that has impr calibration and communication processes. These impr processes allow for easier calibration, easier operation, and greater versatility. The processes also provide more reliable results than with the instruments currently available. In one aspect, the invention features a calibration method for an analyte test instrument that uses one of a plurality of data storage strips. The data storage strips may include one or more memory devices, such as a ROM device, which stores calibration and testing information. The analyte test instrument includes a test port adapted to receive any of a plurality of test strips. data storage, a processor electrically connected to the test port, and a memory that stores a protocol to communicate with each data storage strip. The instrument receives a data storage strip in the test hole. The instrument probes the test hole to identify the data storage strip. When the data storage strip has been identified, the instrument establishes communications with the data storage strip using the protocol that corresponds to the data storage strip. In one embodiment, the information from the data storage strip is downloaded by the instrument and stored in the memory. The information may include parameters of the instrument (v. G., Language and type of instrument), test strip parameters (test strip count and expiration date), and analyte parameters. The data storage strip is rem from the test hole, and a test strip can be inserted into the test hole. Using the information downloaded, the instrument implements a test procedure to perform an analyte test when biological material is supplied, such as when a user provides a sample. In another aspect, the invention provides a method for ensuring that an analyte test instrument is operated using valid calibration and test strips. The instrument includes a test hole adapted to receive a calibration strip or test strip, a processor electrically connected to the test hole, a memory that stores a plurality of test parameters, and a display to display the information to a user . The instrument receives a calibration strip or a test strip in the test hole. The processor has access to the test parameters stored in the memory to determine if one or more of the test parameters is invalid for the test strip. If a test parameter is invoked, an indication of the invalid parameter of the test strip is displayed on the display. In one modality, the test parameters may include test strip count and expiration date, instrument language and instrument type. In some modes, the processor disables the instrument when certain parameters are invalid. In other modes, a warning is displayed when certain parameters are invalid. In yet another aspect, the invention highlights a method for determining the current date and time of events in an analyte instrument operated by battery The events generated by operation of the instrument for test of * _ ¿Ib- ___- ¡t¿¿-? A > * - analytes operated by battery are stored in the memory A value is assigned to each event when such an event is stored in the memory. At some point, a reference date and time are provided to the battery-operated analyte test instrument (eg, they are powered via the user interface). A reference value is assigned to the reference date and time. The current date and time of each event are computed by adjusting the value assigned to each event using the reference value. In still another aspect, the invention provides a method for controlling the operation of an analyte test instrument. An information storage strip is received in the test hole and probed to identify its type. Communications are established with the information storage draft, using the protocol corresponding to the information storage strip, when the information storage strip is identified. The information is then downloaded from the information storage strip to the analyte test instrument, and the analyte test instrument stores the information until after the information storage strip has been removed. In some embodiments, the information download comprises at least a portion of a test procedure that the analyte test instrument uses to perform diagnostic tests. In another embodiment, the analyte test instrument has stored a plurality of test procedures used to conduct one or more diagnostic tests using the - «Ijtt. .uA tfc aafcia.aj. s ^ t instrument for analyte test. In this mode, a control procedure is downloaded that selects one or more of the stored procedures to run. In this way, the information storage strip can reconfigure the analyte test "in the field" to run different types of tests or combinations of tests.

BRIEF DESCRIPTION OF THE DRAWINGS In the drawings, similar reference characters generally refer to the same parts in all different views.

Also, the drawings are not necessarily to scale, emphasis being usually placed on illustrating the principles of the invention. These and other aspects of the invention are more fully described later in the detailed description and accompanying drawings, in which: Figure 1 A is a front perspective view of an analyte test instrument according to one embodiment of the invention . Figure 1 B is an enlarged view of the analyte test instrument shown according to one embodiment of the invention. Figure 2 is a block diagram of an analyte test instrument according to one embodiment of the invention. Figure 3A is a perspective cut away view of a test strip according to an embodiment of the invention.

Figure 3B is a perspective cut-away view of a calibration strip according to one embodiment of the invention. Figure 3C is a perspective cut-away view of a communication interface according to an embodiment of the invention. Figure 4 illustrates examples of vain test strips that can be identified using the system of the invention. Figure 5 is a flow chart illustrating a method of identifying strips according to one embodiment of the invention. Figure 6A is a flow chart illustrating a calibration method according to one embodiment of the invention. Figure 6B is a flow chart illustrating the insertion flow of strips according to one embodiment of the invention. Figure 6C is a flow chart illustrating a resistive calibration method according to one embodiment of the invention. Figure 7 is a flow chart illustrating the determination of date and time according to one embodiment of the invention.

DETAILED DESCRIPTION OF THE INVENTION The present invention features an analyte test instrument that has improved calibration and communication processes, which allow the instrument to be more versatile and easier to calibrate and operate. Before describing the aspects and modalities of the invention in detail, the , * K--. following definitions to aid in the understanding of terminology used. "Sample" describes both an activity and a provisional measurement that results from the activity, which occurs when a sample of blood or fluid is applied to a test strip and excited by a voltage pulse. An analogous signal is detected, then the analog signal is converted to a digital result that is used as a sample. A "glucose test" is an analysis that determines the amount of glucose present in a sample. A "ketone assay" is an analysis that determines the amount of ketones present in a sample. "Phase" describes the time intervals in which a trial is divided. Figure 1A is an illustration of an instrument 100 operating in accordance with one embodiment of the invention. The exterior of the instrument 100 comprises a display 30, a push button 120 and a test hole 1 10. A push button 120 provides the user with control of the analyte test instrument 100. In particular, the push button 120 is used to turn the instrument on and off, call up information stored in the instrument, respond to displayed messages and set some of the configuration control parameters for the instrument. The push button 120 may also provide access to menus generated by the software of the device 240 (Figure 2). In one embodiment, one or more replaceable batteries (not shown) installed via the back side of the instrument provide power for the analyte test instrument 100. It should be understood, however, that any power source capable of providing a suitable direct current (DC) voltage can provide power to the instrument 100. The instrument 100 also features a single, multipurpose 1 1 0 port comprising a slot in which a user inserts test strips (Figure 3A), calibration strips (Figure 3B), or a communication interface device (Figure 3C). These devices and the test hole 1 10 are explained more fully below. Figure 1 B shows a modality of the display 1 30 in greater detail. The display 130 may be a liquid crystal display (LCD) and is used to display the test results, user messages and call information stored in the instrument 100. The results of an assay are displayed in a display 125 that generates three numbers of seven segments. The icons 150 indicate units of measurement (v. G., Mg / dL or mol / L) of the test results and a low battery indication. The display 125, in one embodiment, may display readings with varying levels of precision (v. G., 54.5 mg / dL, 5.45 mg / dL, and the like). A dot matrix message line 135 provides information to the user and can generate up to 10 numerals or up to 9 characters. The information displayed may include time and date _i * -. • information notes (v. G., "Applied blood"), error messages (v. G., "Strip expires"), and configuration control (eg, set time or select a language). The details about these messages and what causes them to be displayed are discussed more fully in the present. The display management software controls the appearance of the display 130 and, in one embodiment, is part of the software 240 of the analyte test instrument (see description of the Figure 2). Display management software can provide the ability to run a long message, toggle two or more series to display a long message, flash a message or a portion of a message, or show alternating messages. In addition, the display management software can provide the instrument 100 with the ability to flash the icons. "(50. When energized, the display management software can support a visual review of the display, ie, the display makes it possible for a user or other entity perform a visual review of the viewer During this process, the icons and pixels of the dot matrix viewer 135 are turned on for a short period (eg, one second) to allow the user to check if the viewer is functioning properly Figure 2 shows a block diagram of an analyte test system implemented according to an embodiment of the invention, Instrument 100 comprises a processing circuit 210, at least one circuit 215 of the device, a push button 120 , a test hole 1 10 and a viewer 1 30. Although not shown, it should be understood that the instrument 1 00 can purchase also provide an energy supply (v. g. , a battery) to provide power to the various electrical components. Circuits 125 of the device may comprise analog, digital or mixed-signal type circuits, specific application integrated circuits (AS ICS), and passive and active electrical components. The circuits 215 of the device perform various electrical functions required by the analyte test instrument, such as operating the display 130, clock functions for a microprocessor 230, and analog-to-digital (A / D) conversion of inputs received in the hole 1 10 test. It should be understood that the functions of the device circuit 215 could be provided by a single electrical component or as part of the processing circuit 210. In one embodiment, the processing circuit 210 comprises a memory 220, a microprocessor 230 and a software 240 of the device in communication with the memory 220 and the microprocessor 230. In one embodiment, the memory 220 comprises 1 K of random access memory (RAM). In some embodiments, the memory 220 has sufficient additional capacity to store a plurality of tests (eg, four hundred and fifty). The software 240 of the device is responsive to the information received in the hole 1 10 test. Software 240 uses the information to * - * - Jj a ^ ££ ^ k control the operation of the instrument 100. The software 240 of the device also provides functionality independent of the test hole 1 10. For example, the software 240 of the device can allow the user to call tests and information of messages, can provide several messages of type warning, error and note, can allow the setting of date and time, can control the transmission of information to devices external, tests] can monitor the energy level and / or battery, and can provide indications to the user if the energy goes down a lot. The test hole 1 10 comprises a slot assembly capable of releasably receiving a strip device, such as a calibration device 270 (which in some embodiments comprises a calibration strip), a test strip 290, or a strip 295 communication interface connector. The test hole 1 10 may have a plurality of contacts capable of electrically coupling with such a strip device when it is inserted into the hole. Once a strip is engaged, the test hole 1 10 enables the processing circuitry 210 to communicate with the inserted strip. For example, the processing circuit 210 may send signals to the test hole 1 10 to determine the identity of the inserted strip. This determination, in some modalities, can be achieved using the system described in the co-pending application that has file number 6622. US. OR 1. In still other embodiments, the identity of the strip can be determined using resistance measurements. In additional modalities, the identity of the strip can be communicated via an external device. In another embodiment, the communication interface connector 295 is inserted into the test hole 1 10 and transmits signals to facilitate the transfer of information from the instrument 100. This aspect is explained more fully below. In the illustrated embodiment, the test hole 1 10 includes six contacts: CH EMO; CH EM 1; NOTOUCH (COMMON); SENS 1; SENS2; and B IASCOM. When a strip is inserted into the test hole 1 10, the main surface of the bottom and the upper main surface of the strip engage with the contacts of the test hole 1 10, whereby the instrument is enabled to identify a pattern of material conductor on the upper main surface and / or the main surface of the bottom of the strip. In one embodiment, the patterns of conductive material in the inserted strip assist in the determination of the type of calibration device 270. In another embodiment, the conductive material patterns of an inserted strip indicate whether the inserted strip is a calibration device 270, a communication interface connector strip 295, or a test strip 290, and, if it is a test strip 290. , the type of test strip (eg, glucose, ketone, etc.). The contact coupling and the strip identification process are described in more detail in the co-pending application that has file number 6622. US. O1. Figure 3A illustrates the test strip 290 in more detail. Δ1 * A plurality of contacts 260 is provided at the end of the test strip that is inserted into the test hole 1 10.

Typically, a drop of blood is placed for testing in an area 265 reaction. When a sufficient amount of blood is deposited in the reaction area, an electrochemical reaction occurs, which causes a flow of electrons that produces an electrical signal, such as a change in current, detectable by the analyte test instrument. The analyte test instrument then converts the detected signal into information that corresponds to analyte information and displays the information to the user. Figure 3B illustrates a ROM type calibration strip 270. In one embodiment, a ROM type calibration strip 270 is associated with a package (not shown) of test strips 290 and contains information specific to that package of test strips 290. The calibration strip 270 has a plurality of contacts at the end which is insertable into the test hole 1 10. In one embodiment, the calibration code 275 and batch number 285 of manufacture are printed on the outside of the strip and are available to the user. In another embodiment, the batch number is stored in ROM 280 in a binary coded decimal format (BCD). The parameters and methods associated with the calibration code 275 and manufacturing batch number 285 are stored in a calibration ROM 280 (hereinafter "ROM 280"), which is in electrical communication with the .. «. rMt * ,. * contacts 260. For example, the ROM 280 encodes information about the algorithms to perform a test based on a strip and a list of parameters that are essential to characterize new chemistry, test strips and marketing requirements. Marketing requirements, in some embodiments, they comprise field codes, language information (eg, pertaining to the language of a package inserted with the calibration device 270), test strip count (ie, number of test strips packed with the device 270). of calibration)! and the similar ones. The calibration device 270 does not itself perform tests. Instead, the calibration strip 270 delivers the necessary parameters and procedures to the instrument to characterize an assay. The ROM 280 has the ability to store and download the parameters of the instrument 100 which describes phases of the test. Through the sequencing of phases, an assay is constructed that compensates the characteristics of test strip, new chemistries and temperature. The ROM parameters are explained more fully in the present. Figure 3C illustrates a communications connector strip 295. In one embodiment, the strip is electrically linked through a flexible cable 298 to a connector 299 adapted to match with a corresponding connector (eg, DB9 connector) in an information processing device, or other external device (not shown). In one embodiment, the external device contains software for communication of information that interfaces with - * »- * - *"> processing circuit 210 and software 240 of the device for the purpose of receiving and processing analyte information and operational information of instrument 100. In addition, it should be understood that many different types can be used of computer connectors with the communications connector strip 295 of the present invention With reference to Figure 4, the strips 400 (Figure 4A), 405 (Figure 4B), 410 (Figure 4C), and 415 (Figure 4D) There are four different types of test strips.Each type of test strip has a different pattern of conductive material 420 on the main surface of the test strip bottom.In one embodiment, these standards define different types of test strips for glucose. In another embodiment, the patterns define different types of test strips for ketones.In another modality, patterns define types of test strips for ketones, glucose or other types. The conductor 42 0 is arranged in such a way that the CHEMO contact and / or the CHEM1 contact can be tied to a COMMON point (or it may not be absolutely connected). The test strip 400 illustrates a test strip in which neither the CHEMO contact nor the CHEM 1 contact is linked to COMMON, which can be used to define a particular type of test strip. Similarly, test strip 410 illustrates the CH EMO contact being electrically bonded to COMMON; test strip 415 illustrates contact CH EM 1 being trically linked to COMMON; and test strip 405 illustrates both the ¿J ^ ^^ ai * ¡contact CH E M 1 and the contact C H E MO being electrically linked to COM MON. Each of these test strips can be used to define a particular type of test strip that is different from others and different from the test strip 400. Using a pull-down technique, as is well understood by those skilled in the art, a circuit 21 of the device such as an AS IC (see Figure 2) identifies the type of test strip by determining the connection pattern of the test strip. conductive material 420. Figure 5 illustrates a method for identifying a device inserted in the test instrument 100 in the test hole 1 10. When a device is inserted into the test hole (step 500), the instrument 100 detects it (step 510) and attempts a series of steps (steps 520 to 570) to determine the type of device inserted. First, the software 240 of the positive probe probes the test hole 1 10 to identify the type of device inserted. In one embodiment, the software 240 of the device attempts to communicate with the device by means of a communications protocol capable of operating with a serial EE-square interface, such as that defined by the Dallas ROM protocol (step 520) of Dallas Semiconductors, Dallas, Texas. As understood by those skilled in the art, such irjterfase provides simple wire communication. If successful, the software 240 of the device proceeds to the ROM calibration procedure illustrated in Figure 6A and 6B (step 530). If it is not successful, j - ** '* * ** - - • * • - ** - the device software 240 attempts to communicate with the device via an alternate protocol (for example, the standard ROM protocol R S-232) ( step 540). If successful, software 240 of the device proceeds to the ROM calibration procedure of Figure 6A (step 530). If the software 240 of the device is unable to communicate with the inserted device by means of predetermined R OM protocols, the software attempts to determine whether the device is a resistive calibration device, where the software 240 of the device determines whether it can be detected and read a precision resistor value (step 550). If successful, the device software 240 proceeds to the resistive calibration procedure. (See step 560 and Figure 6C, described later). If the software 240 of the device is unable to read a precision resistor value, the software 240 of the device puts the instrument 100 into a short standby mode (step 570). During the waiting period, the analyte test instrument expects to communicate with an external device or to receive a blood signal. If nothing is received within a predetermined period of time, the instrument 100 is also turned off (step 590). If a blood signal is received, the signal indicates that a user is performing a diagnostic test. Briefly referring to Figure 3A, as discussed above and in the co-pending application having file number 6622. US .O1, when a test strip 290 of In a manner, when a sample (not shown) is added to the reaction area 265, the sample reacts with an internal circuit. of test strip (not shown) for putting the sample into electrical communication with the contacts 260, and thereby with the test hole 1 0. When the instrument 100 detects the presence of the sample, the software 240 of the device changes the instrument 100 to a test mode and starts the measurement process (step 580). In one embodiment, during a test of the sample, the instrument 100 analyzes the sample by measuring the current through the circuit formed by the sample and the contacts 260. In a further embodiment, the instrument 100 applies current to that circuit for use in measurements. Subsequent The use of such a test strip electrode system to determine the presence and / or concentration of analytes is discussed in U.S. Patent No. 4., 545, 382, issued October 8, 1995 and U.S. Patent No. 4, 71 1, 245, issued December 8, 1987, the descriptions of which are hereby incorporated by reference. A detector system that detects the indicative current of a compound in a liquid mixture, said system emphasizes a test strip adapted for releasable coupling to the signal reading circuit, is discussed in the U.S. Patent. No. 5,509.4i p, the disclosure of which is incorporated herein by reference. If, when a device is inserted into the test instrument 100, a signal is received, so it indicates a communication from an external device, such as a personal computer, mainframe computer or personal assistant (PDA), the instrument 100 then indicates the external device or to indicate that the instrument 100 is ready to receive additional information. Instrument 1 00 also makes the appropriate electrical connections (step 585). Upon receiving information and / or information requirements, the instrument 100 can provide responses as necessary to the external device (step 595). Figure 6A illustrates the ROM calibration procedure for one embodiment of the invention. By identification of the calibration strip 270, the software 240 of the device downloads information from the ROM 280 to the instrument 100 (step 720). In one embodiment, this information is stored in the memory 220. However, the ROM information can be stored anywhere within the instrument 100 as long as the information is accessible even after the calibration device 270 has been removed from the hole 1 10 test. As explained more fully below, the downloaded information comprises parameters and procedures for controlling the operation of the instrument 100. For example, the information may comprise parameters of the instrument, parameters of the test strip, and parameters of the analyte. The parameters of the instrument can include type of language and meter. The parameters of the test strip can -á- iui .- * m ... jm l¿ .. ^ understand test account and expiration date In addition, the downloaded information may include the batch number of the calibration strip 270. After the information from the ROM 280 has been downloaded to the instrument 100, the display 130 shows the batch number downloaded from the calibration device (step 730), as an indication that the calibration is complete. At the same time, the instrument 100 stores the downloaded information in the memory (step 740). The user can then remove the calibration strip 270 from the test hole 1 10 (step 750). The information downloaded remains in the memory for use of the instrument 100 until a new calibration procedure is performed (step 760). In some embodiments, the instrument 100 may store more than one set of calibration information in the memory. For example, an instrument 100 capable of performing tests with a plurality of different types of test strips 290 (eg, glucose, ketones), can store a set of calibration information for each type of test strip 290. In some embodiments, the instrument 100 automatically displays the calibration code associated with a particular type of test strip 290 when the test strip is inserted. In addition, the instrument 100 conducts assays using the calibration information associated with the particular type of test strip 290 that is inserted. The parameters of the ROM 280 may also include marketing parameters, engineering parameters and parameters of uaáibi initiation of trials. The marketing parameters are generally those parameters that vary with the particular package of the test strips 290 that are used, with the type of calibration device 270 that is used, or where the instrument is used (geographically). For example, the ROM 280 may provide information to the instrument 100 about the market in which the pack of test strips is sold or used. This information can influence information about the natural language or group of natural languages that is appropriate with the package and inserts for a package of test strips 290. The strip count is another market parameter that can be provided to the instrument 100 in some embodiments of the invention. The ROM 280 stores the number of test strips 290 included in the case and associated with the calibration strip 270. For example, the calibration strip 270 included with a packet of 50 strips for ketone could store a count of strips of "50", communicating to the instrument 100 that a calibration made with that calibration strip 270 is effective for, at most, 50 Ketone assays. Generally, the strip count associated with a calibration strip 270 for one type of assay (eg, ketone) is not related to the strip count associated with a calibration strip 270 for another type of assay (eg, glucose). This stripe count is useful to prevent the calibration strip 270 associated with a first pack of test strips 290 from being used with another packet of test strips, which is likely to have a calibration code 275 and lot number 275 different from those of ppmer package. In some embodiments, the instrument 1 10 provides a warning message on the display 130 which tells the user that the strip count is exceeded. In other modalities, the user is prevented ("close") from performing tests on instrument 1 10 until the system is calibrated for a new pack of test strips. In still other modalities, both a warning and a closure occur when the strip count is reached. The expiration date of the test strips is another parameter provided in ROM 280. The validity date is useful to avoid erroneous results that may occur when a test is made with an expired test strip. When a user inserts the calibration strip 270 to perform a calibration, the instrument 100 stores the expiration date provided by the ROM 280. If the instrument 100 is not calibrated for a later expiration date when the first date is reached, the instrument 100 may provide the user with a warning, a closure, or both of them. In some embodiments, warning and / or closure occur when a test strip 290 is inserted into the test hole 1 10. In other embodiments, the warning and / or closure occurs as soon as the user turns on the instrument 100. The ROM 280 can provide - also a parameter of the "type of instrument" corresponding to certain characteristics, functions and capabilities of the instrument. This parameter is used to ensure that an incompatible ROM calibration strip is not used to calibrate the instrument. Another market parameter that can be stored in the ROM 280 is a strip activation parameter, which can enable and disable the calibration capabilities of the instrument 1 10. In some embodiments, the strip activation parameter includes resistive calibration information to allow calibration of the instrument by means of resistive calibration. The ROM 280 may also comprise engineering parameters, which control the way in which the instrument 100 performs the tests and, in some cases, what tests the instrument performs. Generally, engineering parameters do not vary by geographic location or market, and are not affected by the expiration date or stripe count. In some embodiments, the engineering parameters comprise a Format I D ROM parameter that identifies the ROM 280 as being of a particular type and version. For example, the ROM parameter Format I D can identify a ROM 280 as being a "glucose" ROM, which means that the ROM 280 is storing tests and parameters to perform glucose assays. This embodiment allows the instrument 100 to identify the calibration strip 270 so that a calibration strip 270 that includes a ROM 280 can configure the .diaflttiíáMIii instrument to perform glucose tests. In some embodiments, this configuration allows the ROM 280 on the calibration strip to provide parameters and procedures to the instrument 100. In other embodiments, when the instrument 100 identifies the calibration strip 270 as being a glucose strip, the software 240 of the device run a glucose procedure by itself. In other words, the software 240 of the device runs a procedure for glucose that the instrument 100 already has in memory, because the procedure has been downloaded from a calibration ROM for glucose. In other modalities, if the ROM Format ID parameter is fixed for "ketone", the selection of the test to run is similar to the technique described in relation to the "glucose" tests. In other modalities still, the ROM Format I D can define other types of diagnostic tests or particular test modes of the instrument. Figure 6B is a block diagram showing the overall strip insertion flow process for one embodiment of the invention. In particular, this figure shows a method for operating the instrument to determine if one or more of the test parameters for the analyte test strips 290 are in error and to show an indication of the invalid strip parameter in the display. During the booting period (step 600), the instrument sequences through the steps in Figure 5 to identify the type of strip. In addition, software 240 of the device determines if the test parameter of the strip expires or the test parameter of the strip count is invalid. These parameters are described in detail later. After the instrument 100 has been calibrated according to the procedure shown in Figure 6A, upon receipt of the test strip, the instrument attempts to determine if some of the test parameters stored in the memory are invalid even before the test strip test is accepted. For example, if a user attempts to recalibrate the instrument 100 with the same calibration device 270 previously used, but if the calibration device 270 has expired, the user would not be allowed to recalibrate using the calibration device 270. Instead, the instrument 1 00 displays an error message (step 620) and then turns itself off (step 680). In another example, if the instrument 100 determines that the parameter of the test strip count has been exceeded, the instrument displays a warning (step 615) before allowing the user to proceed with the test. If the instrument 100 finds no parameter errors of strip and determines that a glucose test strip or ketone test strip has been inserted, the instrument 100 determines whether the instrument has been calibrated for the type of test strip inserted (step 685). If the instrument has not been, a recalibration message is displayed (step 690) instructing the user to recalibrate the instrument 100. However, if the instrument 100 has been calibrated for the type of test strip inserted, the display 130 shows the code corresponding to that of the stored calibration (steps 605 and 610, respectively) before alerting the user to apply blood (step 625). In addition, other information may be presented to the user before notifying the user to apply blood, depending on whether e) meter of the instrument 100 was calibrated with a resistive or ROM gauge. If sapgre is not detected in five minutes, the instrument shuts down (step 680). In addition, if the test strip is removed before blood is detected, a "no-strip" message may be displayed (not shown). After blood is detected (step 626), an "OK" message may be displayed in the text display. After the test the result is displayed on the numerical display (step 635 or 650). Figure 6C illustrates the resistive calibration method, according to one embodiment of the invention. If the software 240 of the device detects that there is a resistive calibration strip in the hole (step 560 of Figure 5 and step 900 of Figure 6C), then the software 240 of the device determines the values of the precision resistors (902). ). From the values of the resistors, a calibration code is determined (step 904). The calibration code is displayed (step 906). Subsequently, the assay information values are determined from the values of the resistors (step 908). In one modality, the assay information values are Test parameters In another embodiment of the invention, the measured resistance value is used to determine an intercept point with the slope in one or more graphical representations of test parameters. In some embodiments, the table or graphical representation of test parameters is stored in a location on the instrument 100. In still other embodiments, the resistance value in particular may also provide an indication of the type of test in which the test is to be used. resistive calibration strip. The following table illustrates an example of how the measured resistance value is used to provide the type and test parameters for it: TABLE 1 Resistance and Type Values and Test Parameters It should be understood, however, that the resistance values and test parameter sets of Table 1 are provided by way of example only. One skilled in the art will recognize that other types of tables, strength values and the like are within the scope of this invention. After the appropriate test parameters are obtained, the parameters are stored in the memory in the instrument 100 (step 910). When the resistive calibration strip is removed from the hole (step 912), the test parameters remain in the memory of the instrument 100 until a new calibration is performed (step 914). Figure 7 illustrates a method for determining the actual date and time of the events of a battery operated test instrument 100 according to one embodiment of the invention. Using this method, software 240 of instrument device 1 00 can determine the correct date and time of a test event when a user has not set the date and time since the batteries were last inserted properly. In one embodiment, the software 240 of the device assumes that the date and time are invalid if the date and time have not been set since the last time a reset power event (POR) was detected. (A POR event will not necessarily occur each time the batteries are replaced). For example, in this mode, the software 240 of the device associates the date and time, and a traffic light "Valid Time", which may be true or false, with each test result. The "Valid Hour" traffic light will be true if and only if date and time are set from the last POR event. In such mode, if the date and time have been set since the last time an event was detected BY, then the date and time have been set appropriately. In some modalities, a POR event can be triggered by the insertion or removal of batteries. In other embodiments, a POR event may be triggered by the removal of the instrument 100 from a power source, such as an external supply of energy, battery pack or other suitable energy source. When a test event occurs (step 800) (v. G., A test), the software 240 of the device first determines whether the date and time have been set appropriately (step 810). In addition, the software of the device associates the date and time of the instrument, together with a traffic light "Valid Time", with each test event. The "Valid Hour" traffic light can be true or false for each test result. The traffic light is true only if the date and time have been set appropriately. If the date and time have not been set appropriately, the software 240 of the device assumes that the date and time of the instrument 100 are invalid. Thus, the software 240 of the device assigns a value to the event, indicates that the semaphore "Valid Time" is false, and stores the value of the event and the traffic light "Valid Time" If the date and time have been set appropriately, then the software 240 of the device assumes that the roof and time of the instrument are valid. Consequently, it stores the date and time of the event and indicates that the "Valid Hour" semaphore is true (step 830). After storing the event, the value (optionally), and the "Valid Time" semaphore (step 840), the device software 240 provides a reference date and time to the analyte test instrument (step 850) and assigns a value reference to the reference date and time (step 860). The reference date and time can represent the current, actual date and time. The reference date and time may be provided to the instrument in any other way from a number of modes. In one embodiment, the software 240 of the device establishes communication between an external device and the test instrument 100, then downloads the reference date and time of the external device. In another embodiment, the reference date and time may be fed using the user interface of the instrument 100 (v. G., The push button 120). A reference value is then assigned to the reference date and time. In one embodiment, the test instrument 100 uses the "Valid Hour" traffic light, reference date, reference value and event value to answer a question for a stored event (eg, during the call of results, show averages , and loaded with information). In addition, the instrument "" - ». .,. t,. - a, a. , jA a i ... | jat., ^ offers a "result call" function that allows a user to see the results stored in the display 130. For each result, if the "Valid Hour" traffic light is true ( step 880), the date and time associated with the result are shown with the result in the display 130 (step 895). If the "Valid Hour" traffic light is false, the date and time associated with the event must be corrected to reflect the correct date and time. This is done by adjusting the value of the event using the reference value and the reference date and time to achieve the correct date and time (step 890) before providing the event information to whoever requires it (step 895). If the question for a stored event is for an average over a period of time, then the software 240 of the device filters the stored results, excluding any result for which the "Valid Hour" traffic light is false. The time periods for such an average can include an average of 7 days, an average of 14 days or an average of 28 days. If an external device requires that a stored event be loaded from the instrument, then the external device adjusts the value of the event by the reference value to achieve the correct date and time (step 890). In one modality, the data delivery delivers results, date and time, and a "Valid Time" traffic light for each result loaded to an external device. In addition, the date and time that the "Valid Time" returned false (beginning of the false period of "Valid Time") can be delivered to the external device. In additional embodiments, when the external device has a date and time capability, the date and time of the external device can be used to provide a reference date and time, and a reference value to the instrument 100. In additional embodiments, the device external can automatically provide a reference date and time as long as the instrument 100 is collected thereto. The following example illustrates the operation of this embodiment of the invention. It assumes that the events in Table 2 are stored in memory 220: TABLE 2 Date and Time of Events In event 1, the "Valid Hour" traffic light is false because a POR event has occurred, but the time and date have not been set since the event POR occurred. Note that the date and time are set to a default value when a POR event occurs, namely 01/01/90 00: 00. This occurs in every POR event (v. G., In the Table) 2, after events 4, 9 and 1 1). As explained below, in some embodiments of the invention, the default date and time help to track the date and time of the test events that occurred even when the "Going Time" light is false. In addition, it should be noted that this default date and time are provided by way of example only and other default dates and times may be used. However, in one mode, it is preferred that the default date and time be selected so that the default date and time will not coincide with a real date and time that may occur. Thus, software 240 of the example instrument includes a default date and time that are several years prior to the date and time when the instrument 100 *** áMém ¿¡k. m¡. ^ ~ imm. is sold In yet another example, the default date and time (as well as the date and time) may be in an annual format of four digits, v g. , 01/01/1990 00: 00, which may be useful to avoid problems that may occur after the year 2000. Referring again to Table 2, in event 2, the date and time are fixed, so that the "Valid Hour" traffic light becomes "true". In event 3, a test occurs, that is, the glucose test displayed. In event 4, the "Hour" traffic light Valid "remains" true "for the results of the test, because the event POR did not occur until one hour after the results, therefore, the date and time of events 6 and 7 (which occur while the traffic light of" Hour " Valid "is" false ") occur in hours in relation to the default POR date and time When the date and time are set in event 8, the" Valid Hour "traffic light changes to" true ", and remains true during the event 9. The event TO after event 9 changes the traffic light from "Valid Time" to "false." Events 1 to 13 all occur while the "Valid Hour" traffic light is "false" (it is to say, it has not happened [gone the restoration of date and time.] Following the events listed in Table 2, a loading of information is done to an external device, taking the information of Table 2, except the notes and event numbers, are provided in the loaded. The loaded includes the date of the instrument of 01/02/90 and time of 02:03 (the time of loading) and includes information regarding the status of the "Valid Hour" traffic light.

UtfÉ IMáiUÉib The date and time of the external device is 8/31/1998 12:02. The external device assumes that each case when the user restores the date and time was done appropriately. Thus, the external device assumes that events marked with dates 8/22/98, 8/23/98 and 8/28/98 are treated as correct and no additional correction is required. Referring to Figure 8, the events that occur at those dates would correspond to a value "true" (steps 880 and 895), so no correction is required. Events marked with dates of 01/02/90 06:06 (evjento 6) and 01/03/90 07:07 (event 7), however, have a "false" value (step 890 of Figure 8) and they require correction. These events can be corrected because the time change event on 08/28/98 indicates a time delta of + 8 years, 7 months, 24 days, 10 hours and 10 minutes. Therefore, the corrected dates and times provided to the external device (step 895) are: TABLE 3 First Corrected Events In this mode, the date and time of the event marked - - * - * - - ** • - "- .. *, >. ,, * .., t .... * ... ¿* * .Lm * it. ** f ... mm. * * & *, - *: .. 01/01/90 01: 01 (event 1 1) can not be determined because the event occurred between two events POR, without a change of time between the two events POR. The date and time of the event marked 01/02/90 02:02 (event 13) can not be determined from the current time on the external device and the time indicated by the software 240 of the device at the time of loading. In this example, there is a time delta of + 8 years, 7 months, 29 days, 10 hours and 0 minutes. Therefore, the corrected event is: TAB LA 4 Additional Event Corrected Any of the embodiments described herein, including all features described herein, may be provided as computer software on a computer-readable medium such as a floppy disk or optical compact disc (CD) for execution on a purpose-built computer. general (eg, an Apple Macintosh, a PC I BM or compatible, a SUN Workstation, etc.). Variations, modifications and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and scope of the invention as claimed. Accordingly, the invention will be defined not by the foregoing illustrative description, but by the spirit and scope of the following claims.

Claims (25)

1. RE IVI N D ICAC ION ES 1. A method for calibrating an analyte test instrument having a test hole adapted to receive any of a plurality of information storage strips, a processor electrically connected to the test port and a memory storing a protocol for communication with each strip for storing information, said method comprising the steps of: (a) receiving in said test hole an information storage strip; (b) probing said test hole to identify said information storage strip; and (c) establishing communications with said information storage strip using a protocol corresponding to said information storage strip. The method of claim 1, wherein said information storage strip comprises a memory device. The method of claim 1, further comprising the steps of: (d) downloading information from said information storage strip to said instrument for analyte testing; and (e) storing said downloaded information in said memory. 4. The method of claim 3, wherein said information comprises instrument parameters, parameters of test strip and analyte parameters. The method of claim 4, wherein said instrument parameters include language type and meter. The method of claim 4, wherein said test strip parameters include test strip count and expiration date. The method of claim 3, further comprising the step of: (f) removing said information storage device from said test hole. The method of claim 3, further comprising the steps of: (g) inserting a test strip into said test hole; and (h) implementing a test procedure using said downloaded information. 9. A method for operating an analyte test instrument having a test hole adapted to receive a test strip or calibration strip, a processor electrically connected to said test hole, and a display to display information, said method comprising the steps of: (a) receiving a test strip in said test hole; (b) access the test parameters stored in a memory; (c) determining if one or more of said test parameters is invalid for said test strip; Y (d) show an indication of the invalid strip parameter in said display. The method of claim 9, wherein said test parameters include test strip counts and expiration dates. eleven . The method of claim 10, further comprising the step of: (e) disabling the analyte test in the instrument when said expiration date has passed. The method of claim 10, further comprising the step of: (e) displaying a warning in said display when said strip count has been exceeded. The method of claim 9, wherein said test parameters include language type and instrument. The method of claim 13, further comprising the step of: (e) disabling the analyte test on said instrument when said instrument language and said type of instrument is invalid. 15. The method of claim 9, wherein said strip is a calibration strip or a test strip. The method of claim 15, wherein said calibration strip comprises a device for storing information and step (a) comprises the steps of: (e) download information from the calibration strip to the analyte test instrument; and (f) store the downloaded information in memory. The method of claim 9, wherein the displayed indication comprises an error message, a warning message or an instruction message. 18. A method to determine the actual date and time of the events in an analyte test instrument, said method comprising the steps of: (a) storing events generated by the operation of said instrument for analyte test in memory; (b) assigning a relative value to the time for each event when such an event is stored in memory; (c) providing a reference date and time to said instrument for analyte testing; and (d) assigning a reference value to said reference date and time; and (e) calculating said actual date and time of each event by adjusting the value assigned to each event using said reference value. The method of claim 18, wherein step (c) further comprises the steps of: (i) establishing communications between an external device and said analyte test instrument; and (ii) download said reference date and time of said external device to said instrument for analyte test. The method of claim 18, wherein said analyte test instrument comprises a user interface step (c) further comprising the step of feeding said reference date and time to said analyte test instrument using said interphase. of user. twenty-one . The method of claim 18, wherein said analyte test instrument is operated by batteries. The method of claim 21, wherein said step of assigning a value to each event comprises assigning a value to each event when such an event is stored in memory and the battery operation of said instrument has been interrupted. 23. A method for controlling the operation of an analyte test instrument having a test hole adapted to receive any of a plurality of information storage strips, a processor electrically connected to the test port and a memory storing a protocol for communication with each information storage strip, said method comprising the steps of: (a) receiving in said test hole an information storage strip; (b) probing said test hole to identify! said information storage strip; and (c) establishing communications with said storage strip of information using a protocol corresponding to said information storage strip; (d) downloading information from said information storage strip to said instrument for analyte testing; (e) storing said downloaded information in said memory; and (f) removing said information storage device from said test hole. The method of claim 23, wherein said step of downloading the information further comprises the step of downloading at least a portion of a test procedure that said analyte test instrument uses to conduct diagnostic tests. 25. The method of claim 25, further comprising the steps of: (g) storing, in the analyte test instrument, a plurality of test procedures used to conduct one or more diagnostic tests using said instrument for test of analytes; and (h) downloading a control procedure of said information storage strip that selects one or more of said stored procedures to run it. u ^^ iMu ... - UB? ¡t3MJí¿.i? ~ .m * .. * ..