METHODS AND SYSTEMS FOR EARLY SIGNAL ATTENUATION DETECTION
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`Docket No. A0130.0090.C7
`9368USC7
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`AND PROCESSING
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`RELATED APPLICATIONS
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`[0001] The present application is a continuation of U.S. Patent Application No. 17/245,719,filed
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`April 30, 2021, which is a continuation of U.S. Patent Application No. 16/228,910,filed
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`December 21, 2018, now U.S. Patent No. 11,013,431, which is a continuation of U.S. Patent
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`Application No. 15/061,774,filed March 4, 2016, now U.S. Patent No. 10,194,844, whichis a
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`continuation of U.S. Patent Application No. 13/925,694, filed June 24, 2013, now U'S. Patent
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`No. 9,310,230, which is a continuation of U.S. Patent Application No. 12/769,635, filed April
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`28, 2010, now U.S. Patent No. 8,483,967, which claims the benefit of U.S. Provisional Patent
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`Application No. 61/173,600, filed April 29, 2009, the disclosures of all of which are incorporated
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`herein by referencein their entireties for all purposes.
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`BACKGROUND
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`[0002] Analyte, e.g., glucose monitoring systems including continuous and discrete monitoring
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`systems generally include a small, lightweight battery powered and microprocessor controlled
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`system which is configured to detect signals proportional to the corresponding measured glucose
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`levels using an electrometer. RF signals may be used to transmit the collected data. One aspect of
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`certain analyte monitoring systems includes a transcutaneousor subcutaneous analyte sensor
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`configuration whichis, for example, at least partially positioned through the skin layer of a
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`subject whoseanalyte level is to be monitored. The sensor may use a twoorthree-electrode
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`(work, reference and counter electrodes) configuration driven by a controlled potential
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`(potentiostat) analog circuit connected through a contact system.
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`[0003] An analyte sensor may be configured so that a portion thereof is placed underthe skin of
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`the patient so as to contact analyte of the patient, and another portion or segmentof the analyte
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`sensor may be in communication with the transmitter unit. The transmitter unit may be
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`configured to transmit the analyte levels detected by the sensor over a wireless communication
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`link such as an RF (radio frequency) communication link to a receiver/monitor unit. The
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`receiver/monitor unit may perform data analysis, among other functions, on the received analyte
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`levels to generate information pertaining to the monitored analyte levels.
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`[0004] Devices and methods for analyte monitoring, e.g., glucose monitoring, and/or therapy
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`management system including, for example, medication infusion devices are provided.
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`SUMMARY
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`Embodiments include transmitting information fromafirst location to a second, e.g., using a
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`9368USC7
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`telemetry system such as RF telemetry. Systems herein include continuous analyte monitoring
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`systems, discrete analyte monitoring system, and therapy managementsystems.
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`[0005] Embodiments include receiving sensor data from an analyte sensor of a sensor
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`monitoring system, processing the received sensor data with time correspondingcalibration data,
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`outputting the processed sensor data, detecting one or more adverse conditions associated with
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`the sensor monitoring system, disabling the output of the sensor data during a adverse condition
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`time period, determining that the one or more detected adverse conditions is no longer present in
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`the sensor monitoring system, retrieving the sensor data during the adverse condition time
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`period, processing the retrieved sensor data during the adverse condition time period, and
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`outputting the processed retrieved sensordata.
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`[0006] Embodiments include detecting a condition unsuitable for calibration of an analyte sensor
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`for a predetermined timeperiod, disabling output of information associated with the analyte
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`sensor, determining a successful calibration of the analyte sensor, retrieving one or more
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`parameters associated with the successful calibration, processing sensor data during the time
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`period of disabled output of information with the one or more parameters associated with the
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`successful calibration, and displaying the processed sensor data for the time period of disabled
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`information output.
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`[0007] Embodiments include an interface configured to receive sensordata, a first memory
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`configured to store the received sensor data, a processor coupled to the memory and configured
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`to process the stored sensor data, a second memory coupled to the processor and configured to
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`store the processed sensor data, and a display unit coupled to the second memory and configured
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`to display the processed sensor data, where the processoris further configured to detect a
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`condition unsuitable for calibration of a sensor for a predetermined time period, disable display
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`of processed sensor data, determine a successful calibration of the sensor, retrieve one or more
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`parameters associated with the successful calibration, process the sensor data during the time
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`period of disabled display of sensor data with the one or more parameters associated with the
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`5.
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`Docket No. A0130.0090.C7
`9368USC7
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`successful calibration, and display the processed sensor data for the time period of disabled
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`information output.
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`[0008] These and other objects, features and advantagesof the present disclosure will become
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`more fully apparent from the following detailed description of the embodiments, the appended
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`claims and the accompanying drawings.
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`INCORPORATION BY REFERENCE
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`[0009] The following patents, applications and/or publications are incorporated herein by
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`referenceforall purposes: U.S. Patent Nos. 4,545,382; 4,711,245; 5,262,035; 5,262,305;
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`5,264,104; 5,320,715; 5,509,410; 5,543,326; 5,593,852; 5,601,435; 5,628,890; 5,820,551;
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`5,822,715; 5,899,855; 5,918,603; 6,071,391; 6,103,033; 6,120,676; 6,121,009; 6,134,461;
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`6,143,164; 6,144,837; 6,161,095; 6,175,752; 6,270,455; 6,284,478; 6,299,757; 6,338,790;
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`6,377,894: 6,461,496; 6,503,381; 6,514,460; 6,514,718; 6,540,891: 6,560,471; 6,579,690:
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`6,591,125: 6,592,745: 6,600,997: 6,605,200: 6,605,201: 6,616,819; 6,618,934: 6,650,471:
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`6,654,625: 6,676,816; 6,730,200; 6,736,957; 6,746,582: 6,749,740; 6,764,581; 6,773,671:
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`6,881,551: 6,893,545; 6,932,892: 6,932,894: 6,942,518: 7,167,818: and 7,299,082; U.S.
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`Published Application Nos. 2004/0186365; 2005/0182306; 2007/0056858; 2007/0068807;
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`2007/0227911; 2007/0233013; 2008/0081977; 2008/0161666; and 2009/0054748; U.S. Patent
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`Application Nos. 11/831,866; 11/831,881; 11/831,895; 12/102,839; 12/102,844; 12/102,847;
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`12/102,855; 12/102,856; 12/152,636; 12/152,648; 12/152,650; 12/152,652; 12/152,657;
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`12/152,662; 12/152,670; 12/152,673; 12/363,712; 12/131,012; 12/242,823; 12/363,712;
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`12/393,921: 12/495,709; 12/698,124; 12/699,653: 12/699,844: 12/714,439; 12/761,372; and
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`12/761,387 and U.S. Provisional Application Nos. 61/230,686 and 61/227,967.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`[0010] FIG.1 illustrates a block diagram of a data monitoring and management system for
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`practicing one or more embodimentsofthe present disclosure;
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`[0011] FIG. 2 is a block diagram ofthe transmitter unit of the data monitoring and management
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`system shown in FIG. 1 in accordance with one embodimentofthe present disclosure;
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`[0012] FIG. 3 is a block diagram ofthe receiver/monitor unit of the data monitoring and
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`management system shown in FIG.
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`| in accordance with one embodimentofthe present
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`disclosure;
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`Be
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`Docket No. A0130.0090.C7
`9368USC7
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`[0013] FIG. 4 illustrates analyte sensor data processing in accordance with one embodimentof
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`the present disclosure;
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`[0014] FIG. 5 illustrates analyte sensor data processing in accordance with one embodimentof
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`the present disclosure;
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`[0015] FIG.6 illustrates backfilling gaps in sensor data in one embodimentof the present
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`disclosure; and
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`[0016] FIGS. 7A and 7Billustrate backfill of gaps of a period of uncalibrated sensor data in one
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`embodiment.
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`DETAILED DESCRIPTION
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`[0017] Before the present disclosure is described in additional detail, it is to be understood that
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`this disclosure is not limited to particular embodiments described, as such may, of course, vary.
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`It is also to be understood that the terminology used herein is for the purpose of describing
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`particular embodiments only, and is not intended to be limiting, since the scope of the present
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`disclosure will be limited only by the appendedclaims.
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`[0018] Where a range of values is provided, it is understood that each intervening value, to the
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`tenth of the unit of the lowerlimit unless the context clearly dictates otherwise, between the
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`upper and lowerlimit of that range and any other stated or intervening value in that stated range,
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`is encompassed within the disclosure. The upper and lowerlimits of these smaller ranges may
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`independently be included in the smaller ranges is also encompassed within the disclosure,
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`subject to any specifically excluded limit in the stated range. Where the stated range includes one
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`or both of the limits, ranges excluding either or both of those included limits are also included in
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`the disclosure.
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`[0019] Unless defined otherwise,all technical and scientific terms used herein have the same
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`meaning as commonly understood by one of ordinary skill in the art to which this disclosure
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`belongs. Although any methods and materials similar or equivalent to those described herein can
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`also be used in the practice or testing of the present disclosure, the preferred methods and
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`materials are now described. All publications mentioned herein are incorporated herein by
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`reference to disclose and describe the methods and/or materials in connection with which the
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`publications are cited.
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`[0020] It must be noted that as used herein and in the appendedclaims,the singular forms “a”,
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`“an”, and “the” include plural referents unless the context clearly dictates otherwise.
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`Docket No. A0130.0090.C7
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`[0021] The publications discussed herein are provided solely for their disclosure prior to the
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`filing date of the present application. Nothing herein is to be construed as an admission that the
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`present disclosure is not entitled to antedate such publication by virtue of prior disclosure.
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`Further, the dates of publication provided may be different from the actual publication dates
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`which may need to be independently confirmed.
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`[0022] As will be apparent to those of skill in the art upon reading this disclosure, each of the
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`individual embodiments described andillustrated herein has discrete components and features
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`which may be readily separated from or combinedwith the features of any of the other several
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`embodiments without departing from the scopeorspirit of the present disclosure.
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`[0023] The figures shown herein are not necessarily drawn to scale, with some components and
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`features being exaggerated forclarity.
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`[0024] As described in further detail below, in accordance with the various embodiments of the
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`present disclosure, there is provided a method and system for positioning a controller unit within
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`a transmission range for close proximity communication, transmitting one or more predefined
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`close proximity commands,and receiving a response packet in response to the transmitted one or
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`more predefined close proximity commands. For example, in one aspect, close proximity
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`communication includes short range wireless communication between communication
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`components or devices, where the communication rangeis limited to about 10 inchesorless,
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`about 5 inchesor less, or about 2 inchesorless, or other suitable, short range or distance between
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`the devices. The close proximity wireless communication in certain embodiments includesa bi-
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`directional communication where a command sending communication device, when positioned
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`within the short communication range or in close proximity to the command receiving
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`communication device, is configured to transmit one or more commandsto the command
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`receiving communication device (for example, when a useractivates or actuates a transmit
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`command button or switch). In response, the command receiving communication device may be
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`configured to perform one or more routines associated with the received command, and/or return
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`or send back a response data packetor signal to the command sending communication device.
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`Example of such functions and or commands may include, but not limited to activation of certain
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`functions or routines such as analyte related data processing, andthelike.
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`[0025] FIG.
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`1 illustrates a data monitoring and management system such as, for example, analyte
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`(e.g., glucose) monitoring system 100 in accordance with one embodimentof the present
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`Docket No. A0130.0090.C7
`9368USC7
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`disclosure. The subject invention is further described primarily with respect to a glucose
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`monitoring system for convenience and such description is in no way intendedto limit the scope
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`of the invention.It is to be understood that the analyte monitoring system may be configured to
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`monitor a variety of analytes, e.g., lactate, and thelike.
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`[0026] Analytes that may be monitored include, for example, acetyl choline, amylase, bilirubin,
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`cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA,
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`fructosamine, glucose, glutamine, growth hormones, hormones, ketones, lactate, peroxide,
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`prostate-specific antigen, prothrombin, RNA,thyroid stimulating hormone, and troponin. The
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`concentration of drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the
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`like), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may also be monitored.
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`More than one analyte may be monitored by a single system, e.g., a single analyte sensor.
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`[0027] The analyte monitoring system 100 includes a sensor unit 101, a data processing and
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`transmitter unit 102 coupleable to the sensor unit 101, and a primary receiver unit 104 which is
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`configured to communicate with the data processing and transmitter unit 102 via a bi-directional
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`communication link 103. The primary receiver unit 104 may befurther configured to transmit
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`data to a data processing terminal 105 for evaluating the data received by the primary receiver
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`unit 104. Moreover, the data processing terminal 105 in one embodiment may be configured to
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`receive data directly from the data processing and transmitter unit 102 via a communication link
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`which may optionally be configured for bi-directional communication. Accordingly, data
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`processing and transmitter unit 102 and/or receiver unit 104 may include a transceiver.
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`[0028] Also shownin FIG.
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`| is an optional secondary receiver unit 106 which is operatively
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`coupled to the communication link and configured to receive data transmitted from the data
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`processing and transmitter unit 102. Moreover, as shownin the Figure, the secondary receiver
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`unit 106 is configured to communicate with the primary receiver unit 104 as well as the data
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`processing terminal 105. Indeed, the secondary receiver unit 106 may be configured forbi-
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`directional wireless communication with each or one of the primary receiver unit 104 and the
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`data processing terminal 105. As discussed in further detail below, in one embodiment of the
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`present disclosure, the secondary receiver unit 106 may be configured to include a limited
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`numberof functions and features as compared with the primary receiver unit 104. As such, the
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`secondary receiver unit 106 may be configured substantially in a smaller compact housing or
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`embodied in a device such as a wrist watch, pager, mobile phone, PDA, for example.
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`Docket No. A0130.0090.C7
`9368USC7
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`Alternatively, the secondary receiver unit 106 may be configured with the sameor substantially
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`similar functionality as the primary receiver unit 104. The receiver unit may be configured to be
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`used in conjunction with a docking cradle unit, for example for one or more of the following or
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`other functions: placementby bedside, for re-charging, for data management, for night time
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`monitoring, and/or bi-directional communication device.
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`[0029] In one aspect sensor unit 101 may include two or more sensors, each configured to
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`communicate with data processing and transmitter unit 102. Furthermore, while only one, data
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`processing and transmitter unit 102, communication link 103, and data processing terminal 105
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`are shown in the embodimentof the analyte monitoring system 100 illustrated in FIG. 1.
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`However,it will be appreciated by one of ordinary skill in the art that the analyte monitoring
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`system 100 may include one or more sensors, multiple transmitter units 102, communication
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`links 103, and data processing terminals 105. Moreover, within the scope of the present
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`disclosure, the analyte monitoring system 100 may be a continuous monitoring system, or semi-
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`continuous, or a discrete monitoring system. In a multi-component environment, each device is
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`configured to be uniquely identified by each of the other devices in the system so that
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`communication conflict is readily resolved between the various components within the analyte
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`monitoring system 100.
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`[0030] In one embodimentof the present disclosure, the sensor unit 101 is physically positioned
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`in or on the body of a user whose analyte level is being monitored. The sensor unit 101 may be
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`configured to continuously sample the analyte level of the user and convert the sampled analyte
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`level into a corresponding data signal for transmission by the data processing and transmitter unit
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`102. In certain embodiments, the data processing and transmitter unit 102 may be physically
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`coupled to the sensor unit 101 so that both devices are integrated in a single housing and
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`positioned on the user's body. The data processing and transmitter unit 102 may perform data
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`processing suchasfiltering and encoding on data signals and/or other functions, each of which
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`correspondsto a sampled analyte level of the user, and in any event data processing and
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`transmitter unit 102 transmits analyte information to the primary receiver unit 104 via the
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`communication link 103. Examples of such integrated sensor and transmitter units can be found
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`in, among others, U.S. Patent Application No. 12/698, 124, incorporated herein by reference.
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`[0031] In one embodiment, the analyte monitoring system 100 is configured as a one-way RF
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`communication path from the data processing and transmitter unit 102 to the primary receiver
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`Page 7 of 54
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`Docket No. A0130.0090.C7
`9368USC7
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`unit 104. In such embodiment, the data processing and transmitter unit 102 transmits the sampled
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`data signals received from the sensor unit 101 without acknowledgementfrom the primary
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`receiver unit 104 that the transmitted sampled data signals have been received. For example, the
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`data processing and transmitter unit 102 may be configured to transmit the encoded sampled data
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`signals at a fixed rate (e.g., at one minute intervals) after the completion of the initial power on
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`procedure. Likewise, the primary receiver unit 104 may be configured to detect such transmitted
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`encoded sampled data signals at predetermined time intervals. Alternatively, the analyte
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`monitoring system 100 may be configured with a bi-directional RF (or otherwise)
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`communication between the data processing and transmitter unit 102 and the primary receiver
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`unit 104.
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`[0032] Additionally, in one aspect, the primary receiver unit 104 may include twosections. The
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`first section is an analog interface section that is configured to communicate with the data
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`processing and transmitter unit 102 via the communication link 103. In one embodiment, the
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`analog interface section may include an RFreceiver and an antenna for receiving and amplifying
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`the data signals from the data processing and transmitter unit 102, whichare thereafter,
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`demodulated with a local oscillator and filtered through a band-passfilter. The second section of
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`the primary receiver unit 104 1s a data processing section which is configured to process the data
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`signals received from the data processing and transmitter unit 102 such as by performing data
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`decoding, error detection and correction, data clock generation, and data bit recovery.
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`[0033] In operation, upon completing the power-on procedure, the primary receiver unit 104 is
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`configured to detect the presence of the data processing and transmitter unit 102 within its range
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`based on, for example, the strength of the detected data signals received from the data processing
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`and transmitter unit 102 and/or a predetermined transmitter identification information. Upon
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`successful synchronization with the corresponding data processing and transmitter unit 102, the
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`primary receiver unit 104 is configured to begin receiving from the data processing and
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`transmitter unit 102 data signals corresponding to the user's detected analyte level. More
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`specifically, the primary receiver unit 104 in one embodimentis configured to perform
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`synchronized time hopping with the corresponding synchronized data processing and transmitter
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`unit 102 via the communication link 103 to obtain the user's detected analytelevel.
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`[0034] Referring again to FIG. 1, the data processing terminal 105 may include a personal
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`computer, a portable computer such as a laptop or a handheld device (e.g., personal digital
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`Docket No. A0130.0090.C7
`9368USC7
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`assistants (PDAs)), and the like, each of which may be configured for data communication with
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`the receiver via a wired or a wireless connection. Additionally, the data processing terminal 105
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`may further be connected to a data network (not shown)for storing, retrieving and updating data
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`corresponding to the detected analyte level of the user.
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`[0035] Within the scope of the present disclosure, the data processing terminal 105 may include
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`an infusion device such as an insulin infusion pump (external or implantable) or the like, which
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`may be configured to administer insulin to patients, and which may be configured to
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`communicate with the receiver unit 104 for receiving, among others, the measured analytelevel.
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`Alternatively, the receiver unit 104 may be configured to integrate or otherwise couple to an
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`infusion device therein so that the receiver unit 104 is configured to administer insulin therapy to
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`patients, for example, for administering and modifying basal profiles, as well as for determining
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`appropriate boluses for administration based on, amongothers, the detected analyte levels
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`received from the data processing and transmitter unit 102.
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`[0036] Additionally, the data processing and transmitter unit 102, the primary receiver unit 104
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`and the data processing terminal 105 may each be configured for bi-directional wireless
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`communication such that each of the data processing and transmitter unit 102, the primary
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`receiver unit 104 and the data processing terminal 105 may be configured to communicate(that
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`is, transmit data to and receive data from) with each other via the wireless communication link
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`103. Morespecifically, the data processing terminal 105 may in one embodiment be configured
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`to receive data directly from the data processing and transmitter unit 102 via the communication
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`link 103, where the communication link 103, as described above, may be configured forbi-
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`[0037] In this embodiment, the data processing terminal 105 which mayinclude an insulin pump,
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`may be configured to receive the analyte signals from the data processing and transmitterunit
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`102, and thus, incorporate the functions of the receiver 104 including data processing for
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`managing the patient's insulin therapy and analyte monitoring. In one embodiment, the
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`communication link 103 may include one or more of an RF communication protocol, an infrared
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`communication protocol, a Bluetooth® enabled communication protocol, an 802.11x wireless
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`communication protocol, or an equivalent wireless communication protocol which would allow
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`secure, wireless communication of several units (for example, per HIPPA requirements) while
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`avoiding potential data collision and interference.
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`-9-
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`Page 9 of 54
`Page 9 of 54
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`Docket No. A0130.0090.C7
`9368USC7
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`[0038] FIG. 2 is a block diagram ofthe transmitter of the data monitoring and detection system
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`shownin FIG.
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`| in accordance with one embodimentofthe present disclosure. Referring to the
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`Figure, the data processing and transmitter unit 102 in one embodimentincludesan analog
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`interface 201 configured to communicate with the sensor unit 101 (FIG. 1), a user input 202, and
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`a temperature measurementsection 203, each of whichis operatively coupled to a transmitter
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`processor 204 such as a central processing unit (CPU). As can be seen from FIG.2, there are
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`provided four contacts, three of which are electrodes--work electrode (W) 210, guard contact (G)
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`211, reference electrode (R) 212, and counter electrode (C) 213, each operatively coupled to the
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`analog interface 201 of the data processing and transmitter unit 102 for connection to the sensor
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`unit 101 (FIG. 1). In one embodiment, each of the work electrode (W) 210, guard contact (G)
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`211, reference electrode (R) 212, and counter electrode (C) 213 may be made using a conductive
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`material that is either printed or etched or ablated, for example, such as carbon which may be
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`printed, or a metal such as a metalfoil (e.g., gold) or the like, which may beetched or ablated or
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`otherwise processed to provide one or more electrodes. Feweror greater electrodes and/or
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`contact may be providedin certain embodiments.
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`[0039] Further showni