Abstract: The invention relates to a test sensor and a heater and thermocouple device for use in a test sensor and other assays, such as a diagnostic test sensor or strip and to a method of manufacturing a test sensor and a device and a method of conducting an assay using the test sensor or device. The invention relates to a test sensor comprising a heater and thermocouple device (100), the heater and thermocouple device (100) comprising: a substrate (10); on the substrate (10), a first layer (12) of a first conductive material of a first conductivity comprising: a first thermocouple element (14); a first connector track (16) connected to the first thermocouple element (14); a resistive heater element (20); and in which at least part of the first thermocouple element (14) is comprised of a portion of the resistive heater element (20); a second layer (22) of a second conductive material of a second conductivity comprising: a second thermocouple element (24) in contact with the first thermocouple element (14) (e.g.

Abstract: The invention provides a vehicle drivable in use by a person walking or running while seated comprising: a frame; a large diameter front wheel non-steerable with respect to the frame, a seat for supporting a user's weight while walking or running, the frame configured to carry the seat suspended on the front wheel, a small diameter, steerable rear wheel journalled to the frame at a steering pivot axis, the seat being rotatable forwardly with respect to the front wheel and comprising a seat base for supporting a user and further comprising a backrest for engaging the user's back in use. The large front wheel may be of approximate diameter of a user's leg (typically an adult human), thus the large front wheel may be of similar size to a bicycle wheel for the user.

Abstract: The invention provides a vehicle drivable in use by a person walking or running whilst seated comprising: a frame; a large diameter front wheel non-steerable with respect to the frame, a seat for supporting a user's weight whilst walking or running, the frame configured to carry the seat suspended on the front wheel, a small diameter, steerable rear wheel journalled to the frame at a steering pivot axis, the seat being rotatable forwardly with respect to the front wheel and comprising a seat base for supporting a user and further comprising a backrest for engaging the user's back in use. The large front wheel may be of approximate diameter of a user's leg (typically an adult human), thus the large front wheel may be of similar size to a bicycle wheel for the user.

Abstract: A method for determining an analyte concentration in blood is described that reduces the effects of hematocrit using a test strip attached to a test meter. The test strip includes a working electrode and a reference electrode. The test meter applies a test voltage between the working electrode and the reference electrode. After a user applies a blood sample containing an analyte onto the test strip, the test meter measures a plurality of test currents for a test time interval.

Abstract: The invention provides an enzyme ink useful in test strips that provides a test strip bias, at the low and high glucose ends, falling within a desired target range. The ink of the invention permits an improved method for the production of single calibration code strip lots with good yields.

Abstract: Various embodiments of a technique in which test strip lots can be prepared without requiring a user to input any calibration information before performing a test measurement with a test strip from the test strip lots. In a first aspect, a method of manufacturing a plurality of test strips by adjusting amount of mediators and working electrode area is described. In another aspect, a method of preparing a reagent ink by adjusting the density of the reagent ink to substantially match a target density is described. In a further aspect, a method using a high numerical Shores Hardness squeegee in conjunction with high pressure is provided. In a further aspect, a method of performing an analyte measurement with a test meter, the test meter being configured to not receive a calibration input, and where the test strip manufactured to any one of the methods or techniques described and illustrated herein.

Abstract: An electrochemical-based analytical test strip for the determination of an analyte (such as glucose) in a bodily fluid sample (e.g., a whole blood sample) includes an electrically-insulating substrate, at least one working electrode disposed on the electrically-insulating substrate and a graded enzymatic reagent layer disposed on the at least one working electrode. The graded enzymatic reagent layer includes an upper reaction grade that contains an enzyme. The graded enzymatic layer also has a lower spacer grade devoid of the enzyme, the lower spacer grade disposed between the upper reaction grade and the working electrode such that the upper reaction grade is spaced equidistant from the working electrode by the lower spacer grade by a predetermined distance during use of the electrochemical-based analytical test strip.

Abstract: The invention provides an enzyme ink useful in test strips that provides a test strip bias, at the low and high glucose ends, falling within a desired target range. The ink of the invention permits an improved method for the production of single calibration code strip lots with good yields.

Abstract: A method for determining an analyte concentration in blood is described that reduces the effects of hematocrit using a test strip attached to a test meter. The test strip includes a working electrode and a reference electrode. The test meter applies a test voltage between the working electrode and the reference electrode. After a user applies a blood sample containing an analyte onto the test strip, the test meter measures a plurality of test currents for a test time interval.

Abstract: An improved disposable glucose test strip for use in a test meter of the type which receives a disposable test strip and a sample of blood from a patient and performs an electrochemical analysis is made using a non-conductive integrated reagent/blood separation layer containing a filler, an enzyme effective to oxidize glucose, e.g., glucose oxidase, and a mediator effective to transfer electrons from the enzyme. The integrated layer formulation is printed over a conductive carbon element to form a working electrode. The filler, for example a silica filler, is selected to have a balance of hydrophobicity and hydrophilicity such that one drying it forms a two-dimensional network on the surface of the conductive element. The response of this test strip is essentially temperature independent over relevant temperature ranges and is substantially insensitive to the hematocrit of the patient.

Abstract: Various embodiments of a technique in which test strip lots can be prepared without requiring a user to input any calibration information before performing a test measurement with a test strip from the test strip lots. In a first aspect, a method of manufacturing a plurality of test strips by adjusting amount of mediators and working electrode area is described. In another aspect, a method of preparing a reagent ink by adjusting the density of the reagent ink to substantially match a target density is described. In a further aspect, a method using a high numerical Shores Hardness squeegee in conjunction with high pressure is provided. In a further aspect, a method of performing an analyte measurement with a test meter, the test meter being configured to not receive a calibration input, and where the test strip manufactured to any one of the methods or techniques described and illustrated herein.

Abstract: A device for training a user in recognition of the user's bodily fluid analyte concentration and concentration trends (such as the user's whole blood glucose concentration and concentration trends) includes an analyte monitoring module, a control module and a sensation generation module. The analyte monitoring module is configured to monitor the user's bodily fluid analyte concentration and to output a monitor signal corresponding to the user's bodily fluid analyte concentration. The control module is configured to receive the monitor signal, convert the monitor signal into a sensation instruction signal corresponding to the user' bodily fluid analyte concentration, and output the sensation instruction signal. The sensation generation module configured to receive the sensation instruction signal and to generate a user-perceived sensation (e.g., a user-perceived vibratory sensation) corresponding to the user's bodily fluid analyte concentration.

Abstract: A method for training a user in recognition of the user's bodily fluid analyte concentration and concentration trends includes monitoring a user's bodily fluid analyte concentration (for example, a user's whole blood glucose concentration) with an analyte monitoring module of a device for training a user in recognition of the user's bodily fluid analyte concentration. The method also includes generating, at a predetermined time interval, using a generation module of the device, a user-perceived sensation (e.g., a user-perceived vibratory sensation) that is proportional the user's bodily fluid analyte concentration in a predetermined manner.

Abstract: The invention described herein includes a screen printing process for depositing carbon electrodes including a method for selectively removing components that degrade the electrochemical performance from the surface of said carbon electrodes. In one embodiment of the present invention, the process includes applying a corona treatment to the carbon electrodes.

Abstract: The invention relates to a timer device capable of performing one or more control actions in response to the time lapsed since a user initiated action took place. The timer device comprises contact means operatable between two conditions, timer means, and means for storing first and second time stamps. The device further comprises control means for setting a first time stamp in response to the contact means being operated between first and second conditions, setting a second time stamp in response to the contact means being operated between the second and first conditions, calculating the time elapsed between the two time stamps, comparing the elapsed time with a preset time value, and performing a control action if the elapsed time is greater than the preset time value.

Abstract: A lancing system includes a lancing device and a meter. The lancing device has a housing, a lancing mechanism disposed at least partially within the housing and configured to lance a target site with a lancet, and an integrated light source. The meter is configured for the analysis of a bodily fluid sample expressed from a target site lanced by the lancing mechanism. Moreover, the light source, in combination with at least the housing, produces an intense beam of light for illumination and a diffuse light that provides a user with spatial awareness.

Abstract: A method for lancing a target site in low ambient light conditions includes employing diffuse light produced by an integrated light source of a lancing device to achieve user spatial awareness in a low ambient light condition. The method further includes illuminating a target site, also in the low ambient light condition, with an intense beam of light from the integrated light source and urging the lancing device against the target site. Subsequently, the target site is lanced with a lancet held by the lancing device.

Abstract: A lancing device includes a housing, a lancing mechanism disposed at least partially within the housing and configured to lance a target site with a lancet, and an integrated light source. The integrated light source, in combination with the housing, produces an intense beam of light for illumination and a diffuse light that provides a user with spatial awareness.

Abstract: A cap for a lancing device includes a cap body with a distal end, a proximal end, an opening through the cap body from the distal end to the proximal end of thereof, and an integrated light source. The distal end of the cap has a target site contact surface and the proximal end is configured for attachment to a lancing device. Moreover, the light source, in combination with the cap body, produces an intense beam of light for illumination and a diffuse light that provides a user with spatial awareness.