US20200116748A1 - Systems and methods for measurement of fluid delivery - Google Patents

Abstract

A method for determining a volume of fluid dispensed into a test housing. The method includes controlling, by a processor, a power source to create a voltage potential across an input electrode arrangement and an output electrode arrangement associated with the input electrode arrangement each coupled to the test housing. The method includes receiving, by the processor, a signal from the output electrode arrangement based on the fluid received into the test housing, and calculating, by the processor, the volume of fluid dispensed into the test housing based on the signal received from the output electrode arrangement. The method includes generating, by the processor, a user interface for display on a display that illustrates the volume of fluid dispensed, and displaying the generated user interface on the display.

Description

TECHNICAL FIELD
• Embodiments of the subject matter described herein relate generally to systems and methods for measuring a fluid delivery by a medical device. More particularly, embodiments of the subject matter relate to systems and methods for electrofluidic measurement of a fluid delivery by a fluid infusion device, such as an insulin infusion device.
BACKGROUND
• Certain diseases or conditions may be treated, according to modern medical techniques, by delivering a medication or other substance to the body of a user, either in a continuous manner or at particular times or time intervals within an overall time period. For example, diabetes is commonly treated by delivering defined amounts of insulin to the user at appropriate times. Some common modes of providing insulin therapy to a user include delivery of insulin through manually operated syringes and insulin pens. Other modern systems employ programmable fluid infusion devices (e.g., insulin pumps) to deliver controlled amounts of insulin to a user.
• A fluid infusion device suitable for use as an insulin pump may be realized as an external device or an implantable device, which is surgically implanted into the body of the user. External fluid infusion devices include devices designed for use in a generally stationary location (for example, in a hospital or clinic), and devices configured for ambulatory or portable use (to be carried by a user). External fluid infusion devices may establish a fluid flow path from a fluid reservoir to the patient via, for example, a set connector of an infusion set, which is coupled to the fluid reservoir.
• Delivery accuracy of the fluid infusion device is necessary to ensure that the patient receives the correct amount of insulin. Generally, each fluid infusion device is subjected to testing to ensure that the amount of fluid delivered by the fluid infusion device is accurate. Current test methods rely on a gravimetric balance. Due to the small amount of fluid delivered by the fluid infusion device, the measurement of the fluid delivered using the gravimetric balance may be influenced by external factors, such as temperature of the testing environment, evaporation, vibrations, humidity and air density.
• Accordingly, it is desirable to provide systems and methods for measuring a delivery of a fluid by a fluid infusion device, such as an insulin infusion device. Moreover, it is desirable to provide systems and methods for measuring an amount of fluid delivered by a fluid infusion device that is resistant to external factors. Furthermore, other desirable features and characteristics will become apparent from the subsequent detailed description and the appended claims, taken in conjunction with the accompanying drawings and the foregoing technical field and background.
BRIEF SUMMARY
• In various embodiments, a test system for measuring a volume of fluid dispensed by a fluid infusion device is provided. The test system includes a test housing. The test housing includes an inlet and an internal channel. The inlet is to be coupled to the fluid infusion device to receive the volume of fluid, and the internal channel is in fluid communication with the inlet. The test system includes an input electrode coupled to the internal channel to be in fluid communication with the volume of fluid, and an output electrode coupled to the internal channel to be in fluid communication with the volume of fluid. The output electrode is coupled to the internal channel so as to be spaced apart from the input electrode. The test system includes a power source configured to create a voltage potential between the input electrode and the output electrode. The volume of fluid in the internal channel conducts current between the input electrode and the output electrode to facilitate measurement of the volume of fluid dispensed by the fluid infusion device.
• Also provided according to various embodiments is a test system for measuring a volume of fluid dispensed by a fluid infusion device. The test system includes a test housing. The test housing includes an inlet and an internal channel. The inlet is to be coupled to the fluid infusion device to receive the volume of fluid, and the internal channel is in fluid communication with the inlet. The test system includes a plurality of input electrodes coupled to the internal channel to be in fluid communication with the volume of fluid, and a plurality of output electrodes coupled to the internal channel to be in fluid communication with the volume of fluid. The plurality of output electrodes is spaced apart from a respective one of the plurality of input electrodes. The test system includes a power source configured to apply a voltage to a respective one of the plurality of input electrodes. The volume of fluid in the internal channel conducts current between the respective one of plurality of input electrodes and a respective at least one of the plurality of output electrodes to facilitate measurement of the volume of fluid dispensed by the fluid infusion device.
• Further provided is a test system for measuring a volume of fluid dispensed by a fluid infusion device. The test system includes a test housing. The test housing includes an inlet and an internal channel. The inlet is to be coupled to the fluid infusion device to receive the volume of fluid, and the internal channel is in fluid communication with the inlet. The test system includes a plurality of input electrodes coupled to the internal channel to be in fluid communication with the volume of fluid, and a plurality of output electrodes coupled to the internal channel to be in fluid communication with the volume of fluid. Each one of the plurality of output electrodes is spaced apart from a respective one of the plurality of input electrodes. The test system includes a power source configured to apply a voltage to a respective one of the plurality of input electrodes. The volume of fluid in the internal channel conducts current between a respective one of plurality of input electrodes and a respective at least one of the plurality of output electrodes to facilitate measurement of the volume of fluid dispensed by the fluid infusion device. Each of the plurality of input electrodes has an end that extends into the internal channel to be in communication with the fluid, and each of the plurality of output electrodes has a second end that extends into the internal channel that is spaced apart from the end of the respective one of the plurality of input electrodes such that a gap is defined within the internal channel between the end of the respective one of the plurality of input electrodes and the second end of respective one of the plurality of output electrodes.
• Also provided according to various embodiments is a method for determining a volume of fluid dispensed into a test housing. The method includes controlling, by a processor, a power source to create a voltage potential across an input electrode arrangement and an output electrode arrangement associated with the input electrode arrangement each coupled to the test housing. The method includes receiving, by the processor, a signal from the output electrode arrangement based on the fluid received into the test housing, and calculating, by the processor, the volume of fluid dispensed into the test housing based on the signal received from the output electrode arrangement. The method includes generating, by the processor, a user interface for display on a display that illustrates the volume of fluid dispensed, and displaying the generated user interface on the display.
• Further provided is a test control system for determining a volume of dispensed fluid. The test control system includes a test housing. The test housing includes an inlet and an internal channel. The inlet is to receive the volume of fluid, and the internal channel is in fluid communication with the inlet. The test control system includes an input electrode arrangement coupled to the test housing, and an output electrode arrangement associated with the input electrode arrangement and coupled to the test housing so as to be spaced apart from the input electrode arrangement. The test control system includes a controller, having a processor, that is configured to: control a power source to supply a voltage to the input electrode arrangement; receive a signal from the output electrode arrangement based on the fluid received into the test housing; calculate the volume of fluid dispensed into the test housing based on the signal received from the output electrode arrangement; generate a user interface for display on a display that illustrates the volume of fluid dispensed; and display the generated user interface on the display.
• This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.
BRIEF DESCRIPTION OF THE DRAWINGS
• A more complete understanding of the subject matter may be derived by referring to the detailed description and claims when considered in conjunction with the following figures, wherein like reference numbers refer to similar elements throughout the figures.
• FIG. 1 is a functional block diagram illustrating an exemplary embodiment of a test system for electrofluidic measurement of a fluid delivery by a fluid infusion device according to various teachings of the present disclosure;
• FIG. 2 is a perspective view of a test housing of the test system ofFIG. 1;
• FIG. 3 is a cross-sectional view of the test housing, taken along line3-3 ofFIG. 2;
• FIG. 4A is a dataflow diagram illustrating a test control system of the test system ofFIG. 1, in accordance with various embodiments;
• FIG. 4B is a continuation of the dataflow diagram ofFIG. 4A;
• FIG. 5 is a dataflow diagram illustrating a test control module of the test control system ofFIGS. 4A and 4B, in accordance with various embodiments;
• FIG. 6 illustrates an exemplary bolus or bolus amount user interface rendered by the test system on a display of a human-machine interface associated with the test system ofFIG. 1, in accordance with various embodiments;
• FIG. 7 illustrates an exemplary bolus error user interface rendered by the test system on the display of the human-machine interface associated with the test system ofFIG. 1, in accordance with various embodiments;
• FIG. 8 illustrates an exemplary basal rate user interface rendered by the test system on the display of the human-machine interface associated with the test system ofFIG. 1, in accordance with various embodiments;
• FIG. 9 illustrates an exemplary basal error user interface rendered by the test system on the display of the human-machine interface associated with the test system ofFIG. 1, in accordance with various embodiments;
• FIG. 10 is a flowchart illustrating a control method for the test system ofFIG. 1, in accordance with various embodiments;
• FIG. 11 is a flowchart illustrating a calibration control method for the test system ofFIG. 1, in accordance with various embodiments;
• FIG. 12 is a flowchart illustrating a bolus test control method for the test system ofFIG. 1, in accordance with various embodiments; and
• FIG. 13 is a flowchart illustrating a basal test control method for the test system ofFIG. 1, in accordance with various embodiments.
DETAILED DESCRIPTION
• The following detailed description is merely illustrative in nature and is not intended to limit the embodiments of the subject matter or the application and uses of such embodiments. As used herein, the word “exemplary” means “serving as an example, instance, or illustration.” Any implementation described herein as exemplary is not necessarily to be construed as preferred or advantageous over other implementations. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.
• Certain terminology may be used in the following description for the purpose of reference only, and thus are not intended to be limiting. For example, terms such as “top”, “bottom”, “upper”, “lower”, “above”, and “below” could be used to refer to directions in the drawings to which reference is made. Terms such as “front”, “back”, “rear”, “side”, “outboard”, and “inboard” could be used to describe the orientation and/or location of portions of the component within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the component under discussion. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import. Similarly, the terms “first”, “second”, and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context.
• As used herein, the term “axial” refers to a direction that is generally parallel to or coincident with an axis of rotation, axis of symmetry, or centerline of a component or components. For example, in a cylinder or disc with a centerline and generally circular ends or opposing faces, the “axial” direction may refer to the direction that generally extends in parallel to the centerline between the opposite ends or faces. In certain instances, the term “axial” may be utilized with respect to components that are not cylindrical (or otherwise radially symmetric). For example, the “axial” direction for a rectangular housing containing a rotating shaft may be viewed as a direction that is generally parallel to or coincident with the rotational axis of the shaft. Furthermore, the term “radially” as used herein may refer to a direction or a relationship of components with respect to a line extending outward from a shared centerline, axis, or similar reference, for example in a plane of a cylinder or disc that is perpendicular to the centerline or axis. In certain instances, components may be viewed as “radially” aligned even though one or both of the components may not be cylindrical (or otherwise radially symmetric). Furthermore, the terms “axial” and “radial” (and any derivatives) may encompass directional relationships that are other than precisely aligned with (e.g., oblique to) the true axial and radial dimensions, provided the relationship is predominately in the respective nominal axial or radial direction. As used herein, the term “transverse” denotes an axis that crosses another axis at an angle such that the axis and the other axis are neither substantially perpendicular nor substantially parallel.
• As used herein, the term module refers to any hardware, software, firmware, electronic control component, processing logic, and/or processor device, individually or in any combination, including without limitation: application specific integrated circuit (ASIC), an electronic circuit, a processor (shared, dedicated, or group) and memory that executes one or more software or firmware programs, a combinational logic circuit, and/or other suitable components that provide the described functionality.
• Embodiments of the present disclosure may be described herein in terms of schematic, functional and/or logical block components and various processing steps. It should be appreciated that such block components may be realized by any number of hardware, software, and/or firmware components configured to perform the specified functions. For example, an embodiment of the present disclosure may employ various integrated circuit components, e.g., memory elements, digital signal processing elements, logic elements, look-up tables, or the like, which may carry out a variety of functions under the control of one or more microprocessors or other control devices. In addition, those skilled in the art will appreciate that embodiments of the present disclosure may be practiced in conjunction with any number of systems, and that the test systems described herein is merely exemplary embodiments of the present disclosure.
• For the sake of brevity, conventional techniques related to signal processing, data transmission, signaling, control, and other functional aspects of the systems (and the individual operating components of the systems) may not be described in detail herein. Furthermore, the connecting lines shown in the various figures contained herein are intended to represent example functional relationships and/or physical couplings between the various elements. It should be noted that many alternative or additional functional relationships or physical connections may be present in an embodiment of the present disclosure.
• The following description relates to various embodiments of a test system for measuring an amount of fluid delivered by a fluid infusion device to determine an accuracy of the fluid infusion device. The test system is a closed system, which is resistant to environmental factors, including temperature of the testing environment, evaporation, vibrations, humidity and air density. The test system provides a user interface to measure an amount of fluid dispensed by a variety of fluid infusion devices to determine a fluid delivery accuracy for the variety of fluid infusion devices, such as insulin infusion devices. The test system further enables precise and accurate measurement of the small amounts of fluid dispensed by the insulin infusion devices, including precise and accurate measurements for nanoliters and microliters dispensed by the insulin infusion devices, which may be used to determine an accuracy of the insulin infusion devices. It should be noted that while the test system is described herein as being used with an insulin infusion device, such as an insulin infusion pump, it will be understood that the test system may be employed with a variety of other fluid infusion devices and/or medical devices. Thus, while the non-limiting examples described below relate to a test system for use with a fluid infusion device used to treat diabetes, embodiments of the disclosed subject matter are not so limited.
• With reference toFIG. 1, a functional block diagram of atest system100 for measuring an amount of fluid delivered by afluid infusion device102 is shown. In this example, thetest system100 includes thefluid infusion device102, aninfusion set104, a fluiddelivery test device106, aninput device108, adisplay110, apower source112 and acontroller114. Theinput device108 and thedisplay110 are part of a human-machine interface116. The human-machine interface116 and thecontroller114 may be associated with a computing device, such as a desktop computer, laptop computer, tablet or other computing device capable of receiving input, displaying output and controlling the fluiddelivery test device106. Generally, thetest system100 measures an amount of fluid dispensed by thefluid infusion device102, compares the measured amount of fluid dispensed to the amount of fluid commanded to be dispensed by thefluid infusion device102 and determines, based on the comparison, whether the amount of fluid delivered by thefluid infusion device102 is accurate. In other embodiments, thetest system100 may be used to calibrate thefluid infusion device102.
• Thefluid infusion device102 dispenses a volume of a fluid118 to the fluiddelivery test device106 through the infusion set104. In one example, thefluid infusion device102 is an insulin infusion device, such as an insulin infusion pump. As thefluid infusion device102 comprises any suitable fluid infusion device known in the art, thefluid infusion device102 will not be discussed in great detail herein. For example, thefluid infusion device102 can comprise an insulin infusion device, such as the MiniMed™ 670G Insulin Pump System, the MiniMed Paradigm® REAL-Time Revel™ Insulin Pump, MiniMed™ 630G Insulin Pump System, MiniMed™ 530G Insulin Pump, MiniMed™ 640G Insulin Pump System each offered for sale by Medtronic MiniMed, Inc. of Northridge, Calif. Briefly, thefluid infusion device102 is designed to be carried or worn by the patient. Thefluid infusion device102 may leverage a number of conventional features, components, elements, and characteristics described in U.S. Pat. Nos. 6,485,465 and 7,621,893, the relevant content of which is incorporated by reference herein. In addition, thefluid infusion device102 may comprise the fluid infusion device described in U.S. Publication No. 2014/0207065, which is incorporated by reference herein.
• Generally, thefluid infusion device102 includes afluid reservoir120, which contains thefluid118. Depending upon the particularfluid infusion device102, thefluid reservoir120 may be removably coupled to thefluid infusion device102 or may be fixedly disposed within thefluid infusion device102. In one example, thefluid reservoir120 can comprise the fluid reservoir described in U.S. Publication No. 2014/0207065, which is incorporated by reference herein. It should be understood, however, that thefluid reservoir120 can comprise anysuitable fluid reservoir120 that is capable of receiving and/or dispensing a fluid, and thus, thefluid reservoir120 is merely an example. Generally, thefluid reservoir120 is pre-filled with the fluid118 prior to initiating a test, and thefluid infusion device102 is primed prior to initiating the test.
• In one example, the fluid118 is an electrically conductive liquid. The fluid118 is an electrolytic solution that has fluid properties that may be generally analogous to the fluid properties of insulin, for example, the fluid118 is Newtonian and the surface energy of the fluid when interfacing with air is not greater than that of water interfacing with air. In this example, the fluid118 is a potassium chloride (KCl) solution. It should be noted that any number of electrolytic solutions may be used for the fluid118, including, but not limited to, a solution containing ammonium sulfate, calcium chloride, sodium chloride, potassium carbonate, sodium phosphate or other salt. In the example of the fluid118 as comprising the potassium chloride solution, the fluid118 has a concentration of about 2.5% by mass potassium chloride, which has a conductivity of about 29.5 millisiemens per centimeter (mS/cm). In one example, the fluid118 may be employed in a test environment having a temperature of about 20 degrees Celsius (° C.).
• Thefluid infusion device102 is controllable by an operator to dispense the fluid118 from thefluid reservoir120 in increments to perform the test. In one example, the operator or user controls thefluid infusion device102, via a human-machine interface of thefluid infusion device102, to dispense the fluid118 from thefluid reservoir120. As is generally known, thefluid infusion device102 includes one or more input devices, which enable the operator to select an amount of the fluid118 to be dispensed from thefluid reservoir120 by thefluid infusion device102. For example, the operator may select to dispense the fluid118 in increments or boluses of a pre-defined discrete volume or at a volume of fluid for a particular period of time (basal rate). For example, a pre-defined volume for a bolus may be about 250 nanoliters (nL). The amount of the fluid118 selected to be dispensed by the operator of thefluid infusion device102 may be input to thecontroller114 via the human-machine interface116. In one example, for each command input by the operator to thefluid infusion device102 to dispense an increment of the fluid118, the operator may input the commanded increment via the human-machine interface116 to thecontroller114. In certain embodiments, thecontroller114 may communicate directly with thefluid infusion device102, over a suitable wireless communication protocol, and may command thefluid infusion device102 to dispense the fluid118 at a particular increment.
• The infusion set104 is fluidly coupled to thefluid reservoir120 of thefluid infusion device102. As the infusion set104 comprises any suitable fluid infusion set known in the art, the infusion set104 will not be discussed in great detail herein. For example, the infusion set104 can comprise an insulin infusion set, such as the MiniMed Quick-set® infusion set offered for sale by Medtronic MiniMed, Inc. of Northridge, Calif. In one example, the infusion set104 includes a flexible tubing orconduit122, which is coupled at one end to aset connector124 and is coupled at an opposite end to aninfusion unit126. Theset connector124 defines a fluid flow path for the fluid118 from thefluid reservoir120. Theinfusion unit126 is fluidly coupled to theconduit122 at a distal end of theconduit122 and provides a fluid pathway from thefluid reservoir120 to the body of the patient. Theinfusion unit126 generally includes a fluid outlet orcannula128. In this example, thecannula128 is fluidly coupled to the fluiddelivery test device106 to deliver the fluid118 from thefluid reservoir120 to the fluiddelivery test device106.
• The fluiddelivery test device106 is in fluid communication with thefluid reservoir120 to receive the fluid118 via the infusion set104. Stated another way, the fluiddelivery test device106 receives the fluid118 from thefluid infusion device102, which is communicated through the fluid flow path defined by the infusion set104. The fluiddelivery test device106 is also in communication with thecontroller114 and thepower source112. In one example, the fluiddelivery test device106 includes atest housing130, a plurality ofinput electrodes132 and a plurality ofoutput electrodes134.
• With reference toFIG. 2, thetest housing130 is shown with theinput electrodes132 and theoutput electrodes134 removed for clarity. As shown inFIG. 2, thetest housing130 is integrally formed, monolithic or one-piece. Thetest housing130 may be composed of a non-conductive material. In this example, thetest housing130 is composed of a polymer-based material, including, but not limited to, Polyjet VeroClear material. Thetest housing130 may be formed through 3D printing or other additive manufacturing techniques, or may be machined, cast, molded, etc. Thetest housing130 includes afirst housing end140 opposite asecond housing end142, afirst housing side144 opposite asecond housing side146, afirst housing surface148 opposite asecond housing surface150 and aninternal channel152.
• In one example, thefirst housing end140 is stepped, and includes aprojection154. It should be noted, however, that thefirst housing end140 may be substantially planar or flat. In this example, theprojection154 defines a cleaning inlet156. The cleaning inlet156 is defined on a surface154aof theprojection154. The cleaning inlet156 is in fluid communication with aninlet158 of theinternal channel152. The cleaning inlet156 enables theinternal channel152 to be cleaned or prepared for another test. For example, a cleaning fluid, such as compressed air or a liquid cleaning solution may be used to remove the fluid118 (FIG. 1) from thetest housing130.
• Thesecond housing end142 is substantially flat or planar, and defines anoutlet port160. Theoutlet port160 is in fluid communication with theinternal channel152, and enables the fluid118 and the cleaning fluid, to exit theinternal channel152 and thetest housing130.
• Thefirst housing side144 interconnects thefirst housing end140 and thesecond housing end142. Thefirst housing side144 defines a plurality of input electrode bores162. In one example, thefirst housing side144 defines about 10 input electrode bores162a-162j. It should be noted; however, that thefirst housing side144 can define any number of input electrode bores162a. . .162n. Each of the input electrode bores162a-162jreceives a respective one of the plurality ofinput electrodes132. In this example, each of the input electrode bores162a-162jis circular or cylindrical, and is in communication with theinternal channel152. Each of theinput electrodes132a-132jare spaced a predetermined distance D apart, and thus, each of the input electrode bores162a-162jare also spaced a predetermined distance apart to accommodate the distance D between each of theinput electrodes132a-132j. In one example, in order to determine the distance D between each of theinput electrodes132a-132j, the following equation is used:
• $\begin{array}{cc}\left(D\pm x_2\right)=\frac{V_m}{\left(A_c\pm x_1\right)}-W_e& \left(1\right)\end{array}$
• Wherein, A_cis the cross-sectional area of theinternal channel152 in millimeters (mm); x₁is the manufacturing tolerance associated with the cross-sectional area of theinternal channel152, which in one example, is a manufacturing tolerance associated with the width and the height of the internal channel152 (in the example of a cylindricalinternal channel152, x₁is the manufacturing tolerance associated with the radius (R_c) of the internal channel152); x₂is the manufacturing tolerance associated with the spacing between each of theinput electrodes132a-132jand each of theoutput electrodes134a-134j, respectively; W_eis the thickness of theinput electrodes132a-132jand theoutput electrodes134a-134jin millimeters (mm), which in this example is the same; V_mis the minimum resolution of fluid volume that is desired to be measured or observed by theoutput electrode134a-134jof thetest system100 in microliters (μL); and D is the distance between each of theinput electrodes132a-132jand each ofoutput electrodes134a-134j, respectively, of the test housing130 (measured between respective ends174a-174j;176a-176j) in millimeters (mm), which in this example is the same. In one example, the distance D is about 2.86 millimeters (mm) to about 3.49 millimeters (mm), based on a radius R_c(FIG. 3) of theinternal channel152 of about 0.87 millimeters (mm) to about 1.06 millimeters (mm) and a desired measured volume V_mof 10 microliters (μL). In one example, the distance D is greater than the radius R_c; however, in other examples, the distance D may be equal to or less than the radius R_c. In other examples, thefirst housing side144 need not include the plurality of input electrode bores162, rather, wiring for the plurality ofinput electrodes132 may be internal to or contained within thetest housing130. Based on the distance D and the known thickness W_eof theinput electrodes132a-132j, each of the input electrode bores162a-162jare defined a predetermined distance apart to ensure the distance D between each of theinput electrodes132a-132jis maintained.
• Thesecond housing side146 interconnects thefirst housing end140 and thesecond housing end142. Thesecond housing side146 defines a plurality of output electrode bores164. In one example, thesecond housing side146 defines about 10 output electrode bores164a-164j. It should be noted; however, that thesecond housing side146 can define any number of output electrode bores164a. . .164n. Each of the output electrode bores164a-164jreceives a respective one of the plurality ofoutput electrodes134. In this example, each of the output electrode bores164a-164jis circular or cylindrical, and is in communication with theinternal channel152. In other examples, thesecond housing side146 need not include the plurality of output electrode bores164, rather, wiring for the plurality ofoutput electrodes134 may be internal to or contained within thetest housing130.
• Each of the output electrode bores164a-164jis associated with a respective one of the input electrode bores162a-162jand each of the output electrode bores164a-164jis also spaced the predetermined distance apart to accommodate the spacing of theoutput electrodes134a-134jthe predetermined distance D apart. Based on the distance D and the known thickness We of theoutput electrodes134a-134j, each of the output electrode bores164a-164jare defined a predetermined distance apart to ensure the distance D between each of theoutput electrodes134a-134jis maintained. As will be discussed, by spacing each of theinput electrodes132a-132jand each of theoutput electrodes134a-134j, respectively, apart by the predetermined distance D, an amount or volume of the fluid118 dispensed by thefluid infusion device102 may be determined by thecontroller114. Generally, each of the output electrode bores164a-164jis offset from a respective one of the input electrode bores162a-162j. In this regard, in this example, the input electrode bores162a-162jare defined such that each one of the input electrode bores162a-162jis defined between a respective pair of the output electrode bores164a-164j. Generally, each input electrode bore162a-162jis defined halfway between adjacent ones of the plurality of output electrode bores164a-164j, which doubles a resolution of a signal received from the plurality ofoutput electrodes134. In this example, the plurality of input electrode bores162a-162jand the plurality of output electrode bores164a-164jare defined in thetest housing130 so as to be near or proximate thesecond housing end142.
• Thefirst housing surface148 interconnects thefirst housing side144 and thesecond housing side146; and interconnects thefirst housing end140 and thesecond housing end142. Thefirst housing surface148 is substantially planar or flat, and defines an infusion setinlet port166. In this example, the infusion setinlet port166 is defined near or proximate thefirst housing end140. The infusion setinlet port166 is sized and configured to receive thecannula128. In one example, the infusion setinlet port166 is substantially cylindrical, and is sized to have a clearance fit with thecannula128. It should be noted that in other embodiments, the infusion setinlet port166 may include a septum or have an interference fit with thecannula128 to provide a fluid seal between thecannula128 and thetest housing130, which inhibits fluid, such as air, from entering thetest housing130. In one example, the infusion setinlet port166 has a diameter D3 of about 1.27 millimeters (mm) and a length L2 of about 9.0 millimeters (mm).
• The infusion setinlet port166 is in fluid communication with theinternal channel152 to provide a fluid flow path from thefluid infusion device102 via the infusion set104 into thetest housing130. As will be discussed, the fluid118 received from thecannula128 of the infusion set104 flows into theinternal channel152 to determine an amount of the fluid118 or a volume of the fluid118 dispensed by thefluid infusion device102. The infusion setinlet port166 is generally defined through thefirst housing surface148 so as to be spaced a distance D2 apart from the input electrode bore162aand the output electrode bore164a.In one example, the distance D2 is about 1.5 millimeters to about 3.5 millimeters (mm), which provides a buffer before the fluid118 contacts the plurality ofinput electrodes132 and the plurality ofoutput electrodes134. The distance D2 also serves as a priming distance, which enables thefluid infusion device102 and thetest housing130 to be primed with the fluid118 prior to the starting of a test. The infusion setinlet port166 is also defined so as to extend along an axis A, which is substantially perpendicular to a longitudinal axis L of thetest housing130. Thefirst housing surface148 also provides a surface for positioning or resting the infusion set104 on thetest housing130. Thesecond housing surface150 interconnects thefirst housing side144 and thesecond housing side146; and interconnects thefirst housing end140 and thesecond housing end142. Thesecond housing surface150 is substantially planar or flat.
• Theinternal channel152 is defined through thetest housing130 from thefirst housing side140 to thesecond housing side142. In one example, theinternal channel152 is defined so as to extend along linearly along the longitudinal axis L of thetest housing130. Theinternal channel152 extends from afirst channel end170 to asecond channel end172. Thefirst channel end170 is in fluid communication with the cleaning inlet156, and thesecond channel end172 is in fluid communication with theoutlet port160. Theinternal channel152 is also in fluid communication with the infusion setinlet port166, each of the plurality of input electrode bores162a-162jand each of the plurality of output electrode bores164a-164j. Generally, with reference toFIG. 3, theinternal channel152 is cylindrical. The plurality of input electrode bores162a-162jand the plurality of output electrode bores164a-164jintersect a diameter of theinternal channel152 and are positioned on opposite sides of theinternal channel152. In one example, theinternal channel152 has a length L3, which is sized to enable a predetermined number of volume measurements of thefluid118. In this example, theinternal channel152 has a length L3 of about 31.2 millimeters (mm) to about 32.2 millimeters (mm), which enables about 10 measurements of about 0.01 milliliters (mL) (10 microliters (μL)). Generally, the fluid118 is received in theinternal channel152 such that in order for the fluid118 to move along theinternal channel152,additional fluid118 must be received through the infusion setinlet port166. Thus, each of the input andoutput electrodes132a,134a;132b,134b. . .132j,134jis capable of measuring a discrete volume of fluid received through the infusion setinlet port166. In certain embodiments, theinternal channel152 may be defined as a discrete component, which is positioned within thetest housing130 instead of being monolithically, integrally formed with or integrally defined within thetest housing130. For example, depending upon the size of the measurements required by thetest housing130, theinternal channel152 may be etched onto a glass substrate and coated with a hydrophobic finish. The glass substrate comprising theinternal channel152 may then be coupled within thetest housing130, via adhesives, ultrasonic welding, mechanical fasteners, etc.
• With reference back toFIG. 1, each of the plurality ofinput electrodes132 receives current at a particular voltage from thepower source112, and each of the plurality ofinput electrodes132 is in communication with thepower source112 to receive the current at the particular voltage. In one example, the input voltage is about 1.0 volts (V). It should be noted, however, that another suitable voltage may be used. In this example, the plurality ofinput electrodes132 include 10input electrodes132a-132j, which are received in a respective one of the input electrode bores162a-162j. It should be noted that the fluiddelivery test device106 may include any number ofinput electrodes132a. . .132n, and a corresponding number of input electrode bores162a. . .162n. In this example, each of theinput electrodes132a-132jcomprises conductive wire. In one example, each of theinput electrodes132a-132jcomprise 30 gauge electrical wire, with one end of theinput electrode132a-132jreceived in a respective one of the input electrode bores162a-162j, and the opposite end of theinput electrode132a-132jcoupled to and in communication with thepower source112 to receive the input current at the particular voltage. In one example, a thickness We of each of theinput electrodes132a-132jis about 0.24 millimeters (mm) to about 0.26 millimeters (mm). With reference toFIG. 3, anend174aof theinput electrode132ais shown received within theinternal channel152. Generally, for each of theinput electrodes132a-132j, the end174a-174jis received within theinternal channel152 so as to be in contact with and in fluid communication with the fluid118 received within theinternal channel152. It should be noted that theinput electrodes132a-132jneed not comprise electrical wire, but rather, any suitable electrode may be employed, including, but not limited to, flat panel electrodes. In the example of flat panel input electrodes, the flat panel input electrodes may be coupled to sidewalls of theinternal channel152.
• Each of the plurality ofoutput electrodes134 receive as input the current applied to the respective one of theinput electrodes132a-132jas conducted by the fluid118 within theinternal channel152. Each of the plurality ofoutput electrodes134 is in communication with thecontroller114 and outputs a signal based on current received from therespective input electrodes132a-132jthrough thefluid118. Stated another way, each of theoutput electrodes134 is in communication with the fluid118 to receive the current applied to therespective input electrode132a-132jthrough the fluid118, and to transmit a signal to thecontroller114 that the current has been received. In other words, a pair of electrodes that comprises aninput electrode132a-132jand anoutput electrode134a-134jis spaced apart by theinternal channel152 that forms an open switch. In this example, theoutput electrodes134a-134jare connected to ground. When the fluid118 is received within theinternal channel152 and is in communication with therespective input electrode132a-132jand the respective one ormore output electrodes134a-134j, the fluid118 closes the switch, allowing the current applied to therespective input electrode132a-132jto transfer through the fluid118 to the respective one ormore output electrodes134a-134j, which results in a current reading or signal being communicated to thecontroller114. Thus, an open circuit (air between theinput electrodes132a-132jand theoutput electrodes134a-134j) yields a signal of zero, and a closed circuit (electrolytic fluid between theinput electrodes132a-132jand theoutput electrodes134a-134j) yields a signal of about 1.0 volt (V) and indicates that the fluid118 has reached aparticular output electrode134a-134j.
• In this example, the plurality ofoutput electrodes134 include 10output electrodes134a-134j, which are received in a respective one of the output electrode bores164a-164j. It should be noted that the fluiddelivery test device106 may include any number ofoutput electrodes134a. . .134nthat correspond to a respective number ofinput electrodes132a. . .132n, and a corresponding number of output electrode bores162a. . .162n. In this example, each of theoutput electrodes134a-134jcomprises conductive wire. In one example, each of theoutput electrodes134a-134jcomprise 30 gauge electrical wire, with one end of theoutput electrodes134a-134jreceived in a respective one of the output electrode bores164a-164j, and the opposite end of theoutput electrodes134a-134jcoupled to and in communication with thecontroller114 to provide thecontroller114 with a signal or the current received. In this example, each of theoutput electrodes134a-134jis associated with a respective input port of thecontroller114 such that thecontroller114 is able to identify theparticular output electrode134a-134jthe current or signal is received from. Generally, a thickness W_eof each of theoutput electrodes134a-134jis the same as the W_eof each of theinput electrodes132a-132j, and in this example, is about 0.24 millimeters (mm) to about 0.26 millimeters (mm). It should be noted that theoutput electrodes134a-134jneed not comprise electrical wire, but rather, any suitable electrode may be employed, including, but not limited to, flat panel electrodes. In the example of flat panel output electrodes, the flat panel output electrodes may be coupled to sidewalls of theinternal channel152.
• With reference toFIG. 3, anend176aof theoutput electrode134ais shown received within theinternal channel152. Generally, for each of theoutput electrodes134a-134j, the end176a-176jis received within theinternal channel152 so as to be in contact with and in fluid communication with the fluid118 received within theinternal channel152. In this example, the end176a-176jof therespective output electrode134a-134jis spaced apart from the end174a-174jof therespective input electrode132a-132jsuch that a gap is defined between the respective end174a-174jand end176a-176jwhen the fluid118 is not disposed between or is devoid from being between the respective input andoutput electrodes132a-132j;134a-134jwithin theinternal channel152. The gap prevents or inhibits a flow of current from therespective input electrode132a-132jto the respective one ormore output electrodes134a-134j. In this example, the gap is filled with air; however, another electrically insulating medium that is hydrophobic may be used.
• With reference back toFIG. 1, theinput device108 and thedisplay110 form the human-machine interface116. Each of theinput device108 and thedisplay110 are in communication with thecontroller114 via a suitable communication medium, such as a bus. Theinput device108 may be configured in a variety of ways. In some embodiments, theinput device108 may include various switches or levers, one or more buttons, a touchscreen interface that may be overlaid on thedisplay110, a keyboard, an audible device, a microphone associated with a speech recognition system, or various other human-machine interface devices.
• Thedisplay110 comprises any suitable technology for displaying information, including, but not limited to, a liquid crystal display (LCD), organic light emitting diode (OLED), plasma, or a cathode ray tube (CRT). In this example, thedisplay110 is an electronic display capable of graphically displaying one or more user interfaces under the control of thecontroller114. Those skilled in the art may realize other techniques to implement thedisplay110 in thetest system100.
• Thepower source112 is in communication with thecontroller114, over a suitable communication medium, such as a bus. Thepower source112 provides a current at a particular voltage to theinput electrodes132a-132j. Generally, thepower source112 creates a voltage potential between theinput electrodes132a-132jand theoutput electrodes134a-134j(as theoutput electrodes134a-134jare tied to ground) when the fluid118 is present, which causes current to flow between therespective input electrode132a-132jand therespective output electrode134a-134jin theinternal channel152. In one example, thepower source112 includes a direct current (DC) source. In this example, thepower source112 outputs a 5 volt (V) pulse width modulation wave, which is reduced to the about 1 volt (V) input voltage with a voltage divider. Alternatively, an H-bridge may also be employed to invert the pulse width modulation wave to increase the input voltage, if desired. In one example, the voltage divider includes two resistors, with one having a resistance of about 3.3 M ohms and the other resistor having a resistance of 1.0 M ohms. In one example, the pulse width is about 0.01% and the frequency is about 5 Hertz (Hz), which reduces clustering of the ions in the fluid118 about therespective output electrode134a-134j. Generally, thepower source112 applies the voltage to each of theinput electrodes132a-132jto create a voltage potential between theinput electrodes132a-132jand theoutput electrodes134a-134jin an alternating pattern to enable the ions in the fluid118 to “reset” and prevent clustering of the electrolytes in the fluid118 onto theoutput electrode134a-134j, which inhibits the flow of thefluid118. This enables the current to flow through the fluid118 for a longer period of time. In one example, thepower source112 applies the input voltage to theinput electrode132aand establishes a voltage potential between theinput electrode132aand theoutput electrode134a, then thepower source112 applies the input voltage to theinput electrode132band establishes a voltage potential between theinput electrode132band theoutput electrode134b, etc., until the input voltage has been applied to the input electrode132jand establishes a voltage potential between the input electrode132jand the output electrode134j; and then thepower source112 returns to apply the input voltage to theinput electrode132a. Thus, thepower source112 is configured to apply the voltage to a respective one of theinput electrodes132a-132jin a sequential pattern; however, it will be understood that thepower source112 may apply the voltage to theinput electrodes132a-132jin any pattern that reduces the clustering of the ions of the fluid118 about theoutput electrodes134a-134j.
• Generally, theoutput electrodes134a-134jread a voltage of either 0 volts (V) or approximately 1.0 volts (V) depending on whether current is flowing through them. In this example, this signal from theoutput electrodes134a-134jrequires amplification since the cutoff for reading digital HIGH by at least oneprocessor180 of thecontroller114 is 3.3V. In order to amplify this signal, in this example, theoutput electrodes134a-134jare each electrically connected to standard Operational Amplifier voltage comparator circuits, such as, for example Operational Amplifier OPA2336, which is commercially available from Texas Instruments, Inc. of Dallas, Texas. The signal of each of theoutput electrodes134a-134jis compared to a reference voltage of 0.5 volt (V). If the voltage from theoutput electrodes134a-134jexceeds the reference voltage, the Operational Amplifier outputs a digital HIGH, andprocessor180 determines that the fluid118 is at the site of thatparticular output electrode134a-134jin theinternal channel152.
• Generally, the distance D between each of theinput electrodes132a-132jand each of theoutput electrodes134a-134jcombined with the dimensions of theinternal channel152 provide the minimum resolution of thistest system100. In this example, theinput electrodes132a-132j, theoutput electrodes134a-134jand their spacing are analogous the graduations on a ruler. The number of graduations (theinput electrodes132a-132jand theoutput electrodes134a-134j) and the distance D each of theinput electrodes132a-132jand each of theoutput electrodes134a-134jare spaced apart from another, respectively, generally dictates how small or large an amount may be measured. For example, in order to measure 1.0 microliters (μL), thetest system100 would include ten graduations or teninput electrodes132a-132jand tenoutput electrodes134a-134jthat are each able to measure 0.1 microliter (μL).
• Thecontroller114 includes theprocessor180 and a computer readable storage device ormedia182. Theprocessor180 can be any custom made or commercially available processor, a central processing unit (CPU), a graphics processing unit (GPU), an auxiliary processor among several processors associated with thecontroller114, a semiconductor based microprocessor (in the form of a microchip or chip set), a macroprocessor, any combination thereof, or generally any device for executing instructions. The computer readable storage device ormedia182 may include volatile and nonvolatile storage in read-only memory (ROM), random-access memory (RAM), and keep-alive memory (KAM), for example. KAM is a persistent or non-volatile memory that may be used to store various operating variables while theprocessor180 is powered down. The computer-readable storage device ormedia182 may be implemented using any of a number of known memory devices such as PROMs (programmable read-only memory), EPROMs (electrically PROM), EEPROMs (electrically erasable PROM), flash memory, or any other electric, magnetic, optical, or combination memory devices capable of storing data, some of which represent executable instructions, used by thecontroller114 in controlling components associated with thetest system100.
• The instructions may include one or more separate programs, each of which comprises an ordered listing of executable instructions for implementing logical functions. The instructions, when executed by theprocessor180, receive and process input signals, perform logic, calculations, methods and/or algorithms for controlling the components of thetest system100, and generate control signals to components of thetest system100 to determine an amount of the fluid118 dispensed by thefluid infusion device102 based on the logic, calculations, methods, and/or algorithms. Although only onecontroller114 is shown inFIG. 1, embodiments of thetest system100 can include any number ofcontrollers114 that communicate over any suitable communication medium or a combination of communication mediums and that cooperate to process the sensor signals, perform logic, calculations, methods, and/or algorithms, and generate control signals to control features of thetest system100.
• In various embodiments, one or more instructions of thecontroller114 are associated with thetest system100 and, when executed by theprocessor180, the instructions receive and process signals from the human-machine interface116 to test the accuracy of thefluid infusion device102. For example, as will be discussed herein, the instructions of thecontroller114, when executed by theprocessor180, determine whether to perform a bolus test, a basal test or to calibrate thetest housing130. In various embodiments, the instructions of thecontroller114 determine an amount of the fluid118 or volume of the fluid118 dispensed by thefluid infusion device102, and output one or more user interfaces for display on the display54 of the human-machine interface116 that illustrate the volume of the fluid118 dispensed by thefluid infusion device102 over time. In various embodiments, the instructions of thecontroller114 determine theoutput electrode134a-134jactivated by the fluid dispensed by thefluid infusion device102, and output one or more user interfaces for display on the display54 of the human-machine interface116 that illustrate the number ofoutput electrodes134a-134jactivated by the fluid over time.
• Generally, prior to performing a test using thetest housing130, thefluid reservoir120 of thefluid infusion device102 is pre-filled with the fluid118, and thefluid reservoir120 is coupled to thefluid infusion device102. The infusion set104 is coupled to thefluid reservoir120, and generally, thefluid infusion device102, to define a fluid flow path from thefluid reservoir120. Theinfusion unit126 is coupled to thefirst housing surface148 of thetest housing130 such that thecannula128 is received within and coupled to the infusion setinlet port166. With thefluid infusion device102 fluidly coupled to thetest housing130, the user may initiate a test of the delivery volume accuracy offluid infusion device102 and/or may initiate a calibration test to calibrate thetest housing130. In one example, thefluid infusion device102 is primed with the fluid118, and thetest housing130 is also at least partially primed with the fluid118 prior to the calibration test or the test of the delivery volume accuracy.
• For example, as shown in more detail with regard toFIGS. 4 and 5, and with continued reference toFIG. 1, dataflow diagrams illustrate various embodiments of atest control system200 of thetest system100, which may be embedded within thecontroller114. Various embodiments of thetest control system200 according to the present disclosure can include any number of sub-modules embedded within thecontroller114. As can be appreciated, the sub-modules shown inFIGS. 4 and 5 may be combined and/or further partitioned to similarly control theinput electrodes132a-132jand determine an amount of fluid dispensed by thefluid infusion device102 based on the activatedoutput electrode134a-134j. Inputs to thetest control system200 may be received from the human-machine interface116 (FIG. 1), received from theoutput electrodes134a-134j(FIG. 1), received from other control modules (not shown) associated with thetest system100, and/or determined/modeled by other sub-modules (not shown) within thecontroller114. In various embodiments, with reference toFIGS. 4A and 4B, thetest control system200 includes a user interface (UI)control module202, acalibration datastore204, acalibration control module206 and atest control module208.
• The user interface (UI)control module202 receivesinput data210. Theinput data210 is received from a user's interaction with the human-machine interface116 (FIG. 1). In one example, theinput data210 comprises testtype input data212, testdevice input data214, setrate input data216,bolus delivery data217, fluidquantity input data218 and endtest data219. The testtype input data212 is a type of test to be performed with thetest system100, and includes, but is not limited to, a selection of a bolus test, a basal test and a calibration test. The testdevice input data214 includes a unique identifier associated with aparticular test housing130; the distance D between each of theinput electrodes132a-132jand each of theoutput electrodes134a-134j, respectively, of thetest housing130; the radius R_cof the cross-sectional area of theinternal channel152 or the cross sectional area A_cof theinternal channel152; a thickness W_eof theinput electrodes132a-132jand theoutput electrodes134a-134j; a manufacturing tolerance associated with the spacing between each of theinput electrodes132a-132j; a manufacturing tolerance associated with the radius R_cof the cross-sectional area of theinternal channel152 or a manufacturing tolerance associated with the cross-sectional area A_cof the internal channel152 (such as a manufacturing tolerance associated with a height and a width of the internal channel152); and the data sampling rate associated with theoutput electrodes134a-134j. These values associated with the testdevice input data214 may be permanently coupled to thetest housing130. The testdevice input data214 may comprise a unique series of alpha-numeric values that are associated with thatparticular test housing130 for use with thetest system100, which are received as input through the human-machine interface116. In other embodiments, the testdevice input data214 of thetest housing130 may comprise a scannable code, including, but not limited to a bar code, QR code, etc., and the testdevice input data214 may be received as input by an optical scanning device coupled to and in communication with thecontroller114 and processed by thecontroller114 to determine the testdevice input data214.
• The setrate input data216 is a pre-defined basal rate for the fluid that is to be dispensed from thefluid infusion device102 during a basal test, which may be received as input when a basal test is selected to be performed. The basal rate is defined as a volume of fluid per unit time. Thebolus delivery data217 is optional input received from the user via the user's manipulation of theinput device108 that indicates that the bolus has been delivered by thefluid infusion device102. The fluidquantity input data218 is an expected or pre-defined volume of fluid to be received into the test housing130 a pre-defined number of times, which may be received as input during a calibration test or a bolus test. In this regard, for a calibration test, pre-defined volumes of fluid may be dispensed into thetest housing130 through the infusion set inlet port166 a predetermined number of times until theoutlet port160 of theinternal channel152 is reached. In one example, a calibrated, high-precision syringe pump may provide the known or pre-defined volume of fluid for delivery into thetest housing130 during a calibration test.
• In a bolus test, a predetermined number of expected volumes of fluid or boluses are to be dispensed into thetest housing130 by thefluid infusion device102. Generally, a bolus test determines an accuracy of thefluid infusion device102 to dispense a number of discrete volumes or boluses of fluid, and the fluidquantity input data218 is a pre-defined number of the discrete volumes to be dispensed into thetest housing130 along with a pre-defined expected volume to be received from thefluid infusion device102. Theend test data219 is input received from the user via the user's manipulation of theinput device108 to end a basal test.
• TheUI control module202 receives and processes the testtype input data212 and determines whether input has been received to select a bolus test, basal test or calibration test. Based on a received selection of a bolus test, theUI control module202 setsbolus test command220 for thetest control module208. Thebolus test command220 instructs thetest control module208 to begin a bolus test. Based on a received selection of a basal test, theUI control module202 setsbasal test command222 for thetest control module208. Thebasal test command222 instructs thetest control module208 to begin a basal test. Based on a received selection of a calibration test, theUI control module202 setscalibration test command224 for thecalibration control module206. Thecalibration test command224 instructs thecalibration control module206 to begin a calibration test.
• TheUI control module202 receives and processes the testdevice input data214. Based on the testdevice input data214, theUI control module202 sets testdevice data226 for thecalibration control module206 and thetest control module208. Thetest device data226 is the unique identifier associated with thetest housing130, the distance D between each of theinput electrodes132a-132jand each of theoutput electrodes134a-134j, respectively, of thetest housing130, the radius R_cof the cross-sectional area of theinternal channel152 or A_cthe cross-sectional area of theinternal channel152, the thickness of theinput electrodes132a-132j, the manufacturing tolerance associated with the spacing between each of theinput electrodes132a-132jand each of theoutput electrodes134a-134j, respectively, the manufacturing tolerance associated with the radius R_cof the cross-sectional area of theinternal channel152 or a manufacturing tolerance associated with the cross-sectional area A_cof the internal channel152 (such as a manufacturing tolerance associated with a height and a width of the internal channel152), and the data sampling rate associated with theoutput electrodes134a-134j.
• TheUI control module202 receives and processes the setrate input data216. Based on the setrate input data216, theUI control module202sets rate data228 for thetest control module208. Therate data228 is the pre-defined basal rate for thefluid infusion device102. TheUI control module202 receives and processes the fluidquantity input data218. Based on the fluidquantity input data218, theUI control module202 sets testfluid quantity data230 for thecalibration control module206 and thetest control module208. The testfluid quantity data230 is the pre-defined volume of fluid to be received into thetest housing130 each of the pre-defined number of times. TheUI control module202 receives and processes thebolus delivery data217. Based on thebolus delivery data217, theUI control module202 sets bolus deliveredcommand261 for thetest control module208. TheUI control module202 receives and processes theend test data219. Based on theend test data219, theUI control module202 setsend test command263 for thetest control module208.
• TheUI control module202 also receives as inputbolus amount data232 from thetest control module208. Thebolus amount data232 is a volume of fluid received from thefluid infusion device102 at each of the pre-defined number of times over a period of time. Based on thebolus amount data232, theUI control module202 generates a bolus or bolus amount user interface (UI)234 for display on thedisplay110 of the human-machine interface116 (FIG. 1). The bolusamount user interface234 graphically and/or textually displays the volume of fluid received from thefluid infusion device102 at each of the pre-defined number of times over the period of time.
• In one example, with reference toFIG. 6, an exemplary bolusamount user interface234 is shown. In this example, the bolusamount user interface234 is a graph, in which “Volume” in microliters (4) is measured along a y-axis300, and “Time” in hours (h) is measured on anx-axis302. In one example, the y-axis300 ranges from about 186.0 4 to about 186.3 4, however, the y-axis300 may have any desired range. Thex-axis302 ranges from 0 to 0.35 hours, however, thex-axis302 may have any desired range. A graphical indicator304, for example, a line, is associated with each discrete volume of fluid received by thetest housing130. As each volume of fluid received by thetest housing130 is discrete during a bolus test, the resultant graph has a plurality of steps or levels, with each step or level denoting a volume of fluid or bolus dispensed for a particular time frame. The steps or levels may be interconnected, as shown, if desired.
• With reference back toFIGS. 4A and 4B, theUI control module202 also receives as inputbolus error data236 from thetest control module208. Thebolus error data236 is an error calculated by thetest control module208 for each bolus received from thefluid infusion device102. Stated another way, as will be discussed, thebolus error data236 is a value of a difference between the testfluid quantity data230 and the fluid received from thefluid infusion device102 at each of the pre-defined number of times, which indicates a fluid delivery accuracy of thefluid infusion device102.
• Based on thebolus error data236, theUI control module202 generates a bolus error user interface (UI)238 for display on thedisplay110 of the human-machine interface116 (FIG. 1). The boluserror user interface238 graphically and/or textually displays the error associated with each volume of fluid received from thefluid infusion device102 at each of the pre-defined number of times.
• In one example, with reference toFIG. 7, an exemplary boluserror user interface238 is shown. In this example, the boluserror user interface238 is a graph, in which “Percent Error” is measured along a y-axis320, and “Bolus Number in the Test Sequence” is measured on an x-axis322. In one example, the y-axis320 ranges from −10 to 25, however, the y-axis320 may have any desired range. The x-axis322 ranges from 0 to 25, however, the x-axis322 may have any desired range. Agraphical indicator326, for example, a circle, is associated with each number of fluid volumes received and is positioned at the error calculated for that particular received volume of fluid. For example, graphical indicator326-1 is associated with the second volume of fluid received in thetest housing130, and has a percent error of about −6.5%; graphical indicator326-2 is associated with the fifteenth volume of fluid received in thetest housing130, and has a percent error of about 11.6%. Each of thegraphical indicators326 may be interconnected with a line, which graphically illustrates the error between each bolus dispensed by thefluid infusion device102. The boluserror user interface238 also includes a mean bolus error may be graphically indicated on the boluserror user interface238 as a dashedline308. The mean bolus error may be calculated by thetest control module208 as an average of the errors calculated by thetest control module208 for each bolus received from thefluid infusion device102. The boluserror user interface238 may also include a key328, which may be superimposed over a portion of the boluserror user interface238. In various embodiments, the boluserror user interface238 may also include a serial number of thefluid infusion device102, which may be received as input to theUI control module202 based on a user's interaction with theinput device108; a date; a time; a number of boluses delivered (from the bolus amount data232); a size or volume of each of the boluses (from the test fluid quantity data230); and the unique identifier of thetest housing130 from the testdevice input data214.
• With reference back toFIGS. 4A and 4B, theUI control module202 also receives as inputbasal rate data240 from thetest control module208. Thebasal rate data240 is a volume of fluid delivered by thefluid infusion device102 over a period of time. Based on thebasal rate data240, theUI control module202 generates a basal rate user interface (UI)242 for display on thedisplay110 of the human-machine interface116 (FIG. 1). The basalrate user interface242 graphically and/or textually displays the volume of fluid delivered by thefluid infusion device102 over the period of time.
• In one example, with reference toFIG. 8, an exemplary basalrate user interface242 is shown. In this example, the basalrate user interface242 is a graph, in which “Volume” in microliters (μL) is measured along a y-axis340, and “Time” in hours (h) is measured on an x-axis342. In one example, the y-axis340 ranges from about 186.0 μL to about 186.3 μL, however, the y-axis340 may have any desired range. The x-axis342 ranges from 0 to 0.35 hours, however, the x-axis342 may have any desired range. A graphical indicator344, for example, a line, is used to illustrate the amount of fluid delivered by thefluid infusion device102 over the period of time.
• With reference back toFIGS. 4A and 4B, theUI control module202 also receives as inputbasal error data244 from thetest control module208. Thebasal error data244 is an error calculated by thetest control module208 for the basal rate received from thefluid infusion device102, and generally includes a maximum error value, minimum error value and an overall error value for the dispensing of the fluid by thefluid infusion device102 over the period of time. Stated another way, as will be discussed, thebasal error data244 is a maximum value, a minimum value and an overall value of a difference between therate data228 and the rate of fluid received from thefluid infusion device102 over the period of time, which indicates a fluid delivery accuracy of thefluid infusion device102. Based on thebasal error data244, theUI control module202 generates a basal error user interface (UI)246 for display on thedisplay110 of the human-machine interface116 (FIG. 1). The basalerror user interface246 graphically and/or textually displays the error associated with the amount of fluid received from thefluid infusion device102 over the period of time.
• In one example, with reference toFIG. 9, an exemplary basalerror user interface246 is shown. In this example, the basalerror user interface246 is a graph, in which “Maximum, Minimum, and Overall Percent Error for Shotcycle Windows” is measured in percent (%) along a y-axis360, and “Number of Shotcycles” is measured on anx-axis362. Generally, thefluid infusion device102 delivers fluid at data points, increments or shotcycles over the pre-defined period of time. In one example, the y-axis360 ranges from −60 to 80, however, the y-axis360 may have any desired range. Thex-axis362 ranges from 0 to 30, however, thex-axis362 may have any desired range. A firstgraphical indicator366, for example, a line with a plurality of raised crosses, graphically indicates a minimum error for thefluid infusion device102 over the number of shotcycles. A secondgraphical indicator368, for example, a line with a plurality of in-line crosses, graphically indicates a maximum error for thefluid infusion device102 over the number of shotcycles. A thirdgraphical indicator370, for example, a dashed line, graphically indicates an overall error for thefluid infusion device102 over the number of shotcycles. The basalerror user interface246 may also include a key372, which may be superimposed over a portion of the basalerror user interface246. In various embodiments, the basalerror user interface246 may also include a serial number of thefluid infusion device102, which may be received as input to theUI control module202 based on a user's interaction with theinput device108; a date; a time; a basal rate (from the rate data228); and the unique identifier of thetest housing130 from the testdevice input data214.
• With reference back toFIGS. 4A and 4B, theUI control module202 also receives as inputbolus activation data248 from thetest control module208. Thebolus activation data248 is data that associates the activation of each of theoutput electrodes134a-134jwith a particular time and a particular volume of fluid received from thefluid infusion device102. Stated another way, thebolus activation data248 identifies which one of theoutput electrodes134a-134jis activated at a particular time by a particular one of the volumes or boluses of fluid. Based on thebolus activation data248, theUI control module202 generates a bolus activation user interface (UI)250 for display on thedisplay110 of the human-machine interface116 (FIG. 1). The bolusactivation user interface250 graphically and/or textually displays the volume of fluid received from thefluid infusion device102 over the period of time.
• With toFIGS. 4A and 4B, theUI control module202 also receives as inputbasal activation data252 from thetest control module208. Thebasal activation data252 is data that associates the activation of each of theoutput electrodes134a-134jwith a particular time and a particular shotcycle of fluid received from thefluid infusion device102. Stated another way, thebasal activation data252 identifies which one of theoutput electrodes134a-134jis activated at a particular time by a particular shotcycle of the fluid delivered by thefluid infusion device102. Based on thebasal activation data252, theUI control module202 generates a basal activation user interface (UI)254 for display on thedisplay110 of the human-machine interface116 (FIG. 1). The basalactivation user interface254 graphically and/or textually displays the volume of fluid delivered by thefluid infusion device102 over the period of time.
• Based on at least one of thebolus activation data248 and thebasal activation data252, theUI control module202 also outputs data log256. The data log256 is a text file, for example, which includes thebolus activation data248, thebasal activation data252 or test device calibration data260 in a list form. The data log256 may also include other characteristics associated with a bolus test or basal test performed by the test system100, including, but not limited to: a date; a type of test (from the test type input data212); a unique identifier of the test housing130 (from the test device input data214); a calibration profile associated with the test housing130 that was used for the determination of the amount of fluid dispensed by the fluid infusion device102 (from calibration data258); a type of electrolyte (which may be received from the user through the input device108 and stored in the media182); a concentration of the electrolyte (which may be received from the user through the input device108 and stored in the media182); settings for the voltage applied to the input electrodes132a-132j(which may be received from the user through the input device108 and stored in the media182); a test number (which may be received from the user through the input device108 and stored in the media182); a protocol number (which may be received from the user through the input device108 and stored in the media182); a type of fluid infusion device102 (which may be received from the user through the input device108 and stored in the media182); a serial number of the fluid infusion device102 (which may be received from the user through the input device108 and stored in the media182); a type of infusion set104 used with the fluid infusion device102 (which may be received from the user through the input device108 and stored in the media182); a lot number of the infusion set104 (which may be received from the user through the input device108 and stored in the media182); a type of test (from the test type input data212); a volume of fluid expected for each fluid delivery (from the fluid quantity input data218); a delivery frequency (which may be received from the user through the input device108 and stored in the media182); a total delivery amount (from the fluid quantity input data218); a sample rate for the output electrodes134a-134j(which may be received from the user through the input device108 and stored in the media182); and notes from the user (which may be received from the user through the input device108 and stored in the media182).
• The data log256 may also include other characteristics associated with a calibration test performed by the test system100, including, but not limited to: a date; a unique identifier of the test housing130 (from the test device input data214); a length of the internal channel152 of the test housing130 (which may be received from the user through the input device108 and stored in the media182); a height of the internal channel152 of the test housing130 (which may be received from the user through the input device108 and stored in the media182); a width of the internal channel152 of the test housing130 (which may be received from the user through the input device108 and stored in the media182); a spacing of the input electrodes132a-132jand/or the output electrodes134a-134j(which may be received from the user through the input device108 and stored in the media182); a type of electrolyte (which may be received from the user through the input device108 and stored in the media182); a concentration of the electrolyte (which may be received from the user through the input device108 and stored in the media182); and settings for the voltage applied to the input electrodes132a-132j(which may be received from the user through the input device108 and stored in the media182). Generally, the settings for the voltage applied to theinput electrodes132a-132jare pre-defined, based on the type ofpower source112 employed with the test system100 (FIG. 1).
• TheUI control module202 also receives as input bolus prompt255 from thetest control module208. Thebolus prompt255 is a command to prompt the user to deliver another volume of fluid or a bolus to the test housing130 (FIG. 1). Based on the receipt of thebolus prompt255, theUI control module202 outputs a prompt user interface (UI)257. Theprompt user interface257 may be a graphical and/or textual notification, which may be superimposed over a portion of a user interface on thedisplay110, which instructs the user to dispense another volume of fluid or a bolus into the test housing130 (FIG. 1). For example, theprompt user interface257 may comprise a pop-up window, which states “Deliver Bolus” or the like.
• TheUI control module202 also receives asinput error flag259 from thetest control module208. Theerror flag259 is a notification that a communication error exists between thetest housing130 and thecontroller114. For example, theerror flag259 indicates that one or more of theinput electrodes132a-132jand/oroutput electrodes134a-134jare uncoupled from or no longer in communication with thecontroller114. Based on theerror flag259, theUI control module202 outputs an error user interface (UI)265. Theerror user interface265 may be a graphical and/or textual notification, which may be superimposed over a portion of a user interface on thedisplay110, which instructs the user that a communication error exists. For example, theerror user interface265 may comprise a pop-up window, which states “Check Electrodes” or the like.
• The calibration datastore204 stores data in the form of a calibration table that correlates the unique identifier of thetest housing130 withcalibration data258 for theparticular test housing130. Thus, the calibration datastore204 stores one or more lookup tables, which providecalibration data258 that corresponds with unique identifier of thetest housing130 received from thetest device data226. In one example, thecalibration data258 stored in thecalibration datastore204 is populated based on the testdevice calibration data268 by thecalibration control module206 during a calibration test. It should be noted, however, that thecalibration data258 stored in thecalibration datastore204 may be pre-defined, or default values.
• Thecalibration control module206 receives as input thecalibration test command224 from theUI control module202. Based on the receipt of thecalibration test command224, thecalibration control module206 receives as input the testfluid quantity data230 and thetest device data226 from theUI control module202. Thecalibration control module206 sets a counter equal to zero. Thecalibration control module206outputs voltage data262. Thevoltage data262 is one or more control signals to thepower source112 to alternate and apply the voltage to therespective input electrodes132a-132j. Based on the output of thevoltage data262, thecalibration control module206 receives asinput activation data264. Theactivation data264 is the signal received from the respective one of theoutput electrodes134a-134jbased on the voltage potential created by the voltage applied to therespective input electrode132a-132jthat when the fluid118 is present causes the current to pass through the fluid118 within the internal channel152 (FIG. 3) to therespective output electrode134a-134j. In one example, thecalibration control module206 determines, based on theactivation data264, whether theoutput electrode134aand/or theoutput electrode134bhas been activated such that the voltage applied to theinput electrode132ahas caused current to pass through the fluid118 in theinternal channel152 to therespective output electrode134aand/or134b, which indicates that thetest housing130 has been primed with thefluid118. Thecalibration control module206 also determines, based on theactivation data264, which of theoutput electrodes134a-134jis activated by the fluid118 flowing within the internal channel152 (FIG. 3). Based on the current increment of the counter, thecalibration control module206 determines which pre-defined volume of fluid was received into thetest housing130 based on the testfluid quantity data230. In this regard, as the testfluid quantity data230 generally includes an ordered listing of the pre-defined volumes of fluid to be received into thetest housing130, thecalibration control module206 determines which pre-defined volume of fluid was received based on the count of the counter.
• Thecalibration control module206 associates the identified pre-defined volume of fluid received into thetest housing130 with the respective one or more of the activatedoutput electrode134a-134jfor theparticular test housing130 identified in thetest device data226, and stores this data as testdevice calibration data268 in thecalibration datastore204. Thecalibration control module206 determines whether each of theoutput electrodes134a-134jhas been activated. Thecalibration control module206 repeats this process until each of theoutput electrodes134a-134jhas been activated. If each of theoutput electrodes134a-134jhas been activated, thecalibration control module206 outputs stopvoltage command270. Thestop voltage command270 is one or more control signals to thepower source112 to stop the application of the voltage to theinput electrodes132a-132j. Thecalibration control module206 also sets the testdevice calibration data268 for theUI control module202. Generally, the testdevice calibration data268 indicates a known volume of fluid to activate eachoutput electrode134a-134jin theinternal channel152 over an entire length of theinternal channel152.
• For example, a delivery amount of250 nanolitres (nL) is designed to cover or activate 10output electrodes134a-134j. While delivering the calibrated amount of 250 nanolitres (nL) during an exemplary calibration test, nineoutput electrodes134a-134jare determined to be activated. Thecalibration control module206 determines that nineoutput electrodes134a-134jare activated per 250 nanolitres (nL) and sets this as the testdevice calibration data268.
• With reference toFIG. 5, a dataflow diagram illustrates various embodiments of thetest control module208 of thetest control system200, which may be embedded within thecontroller114. Various embodiments of thetest control module208 according to the present disclosure can include any number of sub-modules embedded within thecontroller114. As can be appreciated, the sub-modules shown inFIG. 5 may be combined and/or further partitioned to similarly control theinput electrodes132a-132jand determine an amount of fluid dispensed by thefluid infusion device102 based on the activatedoutput electrode134a-134j. In various embodiments, thetest control module208 includes a testdevice manager module400, anelectrode control module402, abolus datastore404, abolus monitor module406, abasal datastore408 and abasal monitor module410.
• The testdevice manager module400 receives as inputtest device data226 from the UI control module202 (FIGS. 4A and 4B). Based on thetest device data226, the testdevice manager module400 queries the calibration datastore204 (FIGS. 4A and 4B), and retrieves thecalibration data258 associated with the unique identifier of the test housing130 (from the test device data226). The testdevice manager module400 sets thetest device data226 and thecalibration data258 ashousing data412 for thebolus monitor module406 and thebasal monitor module410. Thehousing data412 includes thecalibration data258 associated with the identifiedtest housing130, along with the distance D between each of theinput electrodes132a-132jand each of theoutput electrodes134a-134j, respectively, of thetest housing130, the radius R_cof the cross-sectional area of theinternal channel152 or the cross-sectional area A_cof theinternal channel152, the thickness of theinput electrodes132a-132j, the manufacturing tolerance associated with the spacing between each of theinput electrodes132a-132jand each of theoutput electrodes134a-134j, respectively, the manufacturing tolerance associated with the radius R_cof the cross-sectional area of theinternal channel152 or a manufacturing tolerance associated with the cross-sectional area of the internal channel152 (such as a manufacturing tolerance associated with a height and a width of the internal channel152), and the data sampling rate associated with theoutput electrodes134a-134j.
• Theelectrode control module402 receives as input astart command414 from thebolus monitor module406 or thebasal monitor module410. Thestart command414 is an instruction to apply a voltage to theinput electrodes132a-132j. Based on thestart command414, theelectrode control module402 outputs thevoltage data262 to thepower source112. Theelectrode control module402 also receives as input astop command416 from thebolus monitor module406 or thebasal monitor module410. Thestop command416 is an instruction to stop applying a voltage to theinput electrodes132a-132j. Based on thestop command416, theelectrode control module402 outputs thestop voltage command270 to thepower source112.
• The bolus datastore404 stores thebolus activation data248 associated with a bolus test. Thus, the bolus datastore404 stores one or more tables, which provide thebolus activation data248 that corresponds with a particular discrete volume of fluid or bolus dispensed into thetest housing130. In one example, thebolus activation data248 stored in thebolus datastore404 is populated by thebolus monitor module406 during a bolus test.
• Thebolus monitor module406 receives as input thebolus test command220 from theUI control module202. Based on the receipt of thebolus test command220, thebolus monitor module406 sets thestart command414 for theelectrode control module402, and sets a value of a counter as equal to one. In one example, thebolus monitor module406 may also set thebolus prompt255 for theUI control module202 to instruct the user to dispense the bolus into thetest housing130, and may determine if the bolus deliveredcommand261 has been received from theUI control module202. Thebolus monitor module406 receives as input theactivation data264. In one example, thebolus monitor module406 determines, based on theactivation data264, whether theoutput electrode134aand/or theoutput electrode134bhas been activated such that the voltage applied to theinput electrode132ahas caused current to pass through the fluid118 in theinternal channel152 to therespective output electrode134aand/or134b, which indicates that thetest housing130 has been primed with thefluid118.
• Thebolus monitor module406 also receives asinput time data266 and the testfluid quantity data230. Thetime data266 is a current time, which may be received from other modules associated with thetest control module208, such as an internal clock associated with theprocessor180. Thebolus monitor module406 also determines, based on theactivation data264 and thetime data266, which of theoutput electrodes134a-134jhave been activated by the fluid118 received into theinternal channel152 and at what time. Based on the current increment of the counter and the testfluid quantity data230, thebolus monitor module406 determines which volume of fluid was received into thetest housing130. Thebolus monitor module406 associates the delivery of the fluid with the activatedoutput electrodes134a-134j, and stores this as thebolus activation data248 in thebolus datastore404. Thebolus monitor module406 also sets thebolus activation data248 for the UI control module202 (FIGS. 4A and 4B).
• Thebolus monitor module406 also receives as input thehousing data412. Based on thehousing data412 and theactivation data264, thebolus monitor module406 determines thebolus amount data232. In one example, thebolus monitor module406 uses the following equation to determine the volume of fluid received from thefluid infusion device102 for the bolus:
• 
  (A_c±x₁)((D±x₂)+W_e)=V  (2)
• Wherein, A_cis the cross-sectional area of theinternal channel152 in millimeters (mm); x₁is the manufacturing tolerance associated with the cross-sectional area of theinternal channel152, which in one example, is a manufacturing tolerance associated with the width and the height of the internal channel152 (in the example of a cylindricalinternal channel152, xi is the manufacturing tolerance associated with the radius (Re) of the internal channel152); D is the distance between each of theinput electrodes132a-132jand each ofoutput electrodes134a-134j, respectively, of the test housing130 (measured between respective ends174a-174j;176a-176j, which in this example is the same) in millimeters (mm); x₂is the manufacturing tolerance associated with the spacing between each of theinput electrodes132a-132jand each of theoutput electrodes134a-134j, respectively; We is the thickness of theinput electrodes132a-132jand theoutput electrodes134a-134jin millimeters (mm); and V is the discrete volume of fluid observed by theoutput electrode134a-134jin cubic millimeters (mm³). In this example, A_c, D, x₁, x₂and W_eare all pre-determined or pre-defined known values that are received ashousing data412. In one example, the A_cis the cross-sectional area of theinternal channel152 and in this example, A_c=π(R_c)², wherein R_cis the pre-defined known value of the radius of theinternal channel152. In this example, A_cof theinternal channel152 may be calculated by theprocessor180 based on the known value of R_c, which is received in thehousing data412. By having current pass through a givenoutput electrode134a-134j, thebolus monitor module406 determines how far the fluid118 has traveled and, based on equation (2) and thecalibration data258, calculates how much volume of fluid has been delivered. In this regard, based on thecalibration data258 retrieved with thehousing data412, thebolus monitor module406 compares the determined volume V of fluid from equation (2) with thecalibration data258 and determines the volume of fluid delivered. Referencing the prior example, if nineoutput electrodes134a-134jhave been activated, thebolus monitor module406 determines that 250 nanolitres (nL) has been delivered. Thebolus monitor module406 associates the volume of fluid delivered with the particular pre-defined volume of fluid or bolus received (based on the count of the counter) as thebolus amount data232 for the UI control module202 (FIGS. 4A and 4B).
• Based on thebolus amount data232 and the testfluid quantity data230, thebolus monitor module406 determines thebolus error data236. In one example, thebolus monitor module406 divides the determined volume of fluid delivered with the expected volume of fluid received as input in the testfluid quantity data230 and multiplies the value by100 to arrive at a percent error for the particular bolus received from thefluid infusion device102. Thebolus monitor module406 sets thebolus error data236 for the UI control module202 (FIGS. 4A and 4B).
• After determining the volume of fluid delivered, thebolus monitor module406 increments the counter by one. Thebolus monitor module406 determines whether the counter is greater than a pre-defined threshold count. In one example, the pre-defined threshold count is about 25. If the counter is less than the pre-defined threshold count, thebolus monitor module406 setsbolus prompt255 for theUI control module202.
• Once thebolus monitor module406 ceases to receiveactivation data264 such that theoutput electrodes134a-134jare no longer being activated, thebolus monitor module406 sets thestop command416 for theelectrode control module402. Thebolus monitor module406 may also set theerror flag259 for theUI control module202 based onactivation data264 not being received from one or more of theoutput electrodes134a-134j.
• Thebasal datastore408 stores thebasal activation data252 associated with a basal test. Thus, thebasal datastore408 stores one or more tables, which provide thebasal activation data252 that corresponds with a particular volume of fluid received over a period of time or basal rate dispensed into thetest housing130. In one example, thebasal activation data252 stored in thebasal datastore408 is populated by thebasal monitor module410 during a basal test.
• Thebasal monitor module410 receives as input thebasal test command222 from theUI control module202. Based on the receipt of thebasal test command222, thebasal monitor module410 sets thestart command414 for theelectrode control module402, and sets a value of a timer as equal to zero. Thebasal monitor module410 receives as input theactivation data264. In one example, thebasal monitor module410 determines, based on theactivation data264, whether theoutput electrode134aand/or theoutput electrode134bhas been activated such that the voltage applied to theinput electrode132ahas caused current to pass through the fluid118 in theinternal channel152 to therespective output electrode134aand/or134b, which indicates that thetest housing130 has been primed with thefluid118.
• Thebasal monitor module410 also receives as input thetime data266 and therate data228. Thebasal monitor module410 determines, based on theactivation data264 and thetime data266, which of theoutput electrodes134a-134jhave been activated by the fluid118 received into theinternal channel152 and at what time by a particular shotcycle. Based on the current time of the timer, thebasal monitor module410 associates the delivery of the fluid118 with the activatedoutput electrodes134a-134j, and stores this as thebasal activation data252 in thebasal datastore408. Generally, the particular shotcycle is determined based on thefluid infusion device102 being employed with thetest system100 and the repeating patterns of discrete fluid deliveries thefluid infusion device102 may employ or the smallest amount of time and volume that is desired to be evaluated for a given basal rate. The shotcycles associated with the particularfluid infusion device102 and/or the smallest of amount of time and volume that is desired to be evaluated may be received as input data from the operator, or may be pre-defined and stored in thememory182 associated with theprocessor180. Thebasal monitor module410 also sets thebasal activation data252 for the UI control module202 (FIGS. 4A and 4B).
• Thebasal monitor module410 also receives as input thehousing data412. Based on thehousing data412 and theactivation data264, thebasal monitor module410 determines thebasal rate data240. In one example, thebasal monitor module410 uses equation (3), below, to determine the volume of fluid received from thefluid infusion device102 over a period of time:
• $\begin{array}{cc}\frac{\left(A_c\pm x_1\right)\left(\left(D\pm x_2\right)+W_e\right)}{t}=V_r& \left(3\right)\end{array}$
• Wherein, A_cis the cross-sectional area of theinternal channel152 in millimeters (mm); x₁is the manufacturing tolerance associated with the cross-sectional area of theinternal channel152, which in one example, is a manufacturing tolerance associated with the width and the height of the internal channel152 (in the example of a cylindricalinternal channel152, x₁is the manufacturing tolerance associated with the radius (R_c) of the internal channel152); D is the distance between each of theinput electrodes132a-132jand each of theoutput electrodes134a-134j, respectively, of the test housing130 (measured between respective ends174a-174j;176a-176j, which in this example is the same) in millimeters (mm); x₂is the manufacturing tolerance associated with the spacing between each of theinput electrodes132a-132jand each of theoutput electrodes134a-134j, respectively; W_eis the thickness of theinput electrodes132a-132jand theoutput electrodes134a-134jin millimeters (mm); t is the time of the timer (in seconds) and V_ris the volume of fluid observed by theoutput electrode134a-134jper the period of time measured by the timer in cubic millimeters per second (mm³/s). As discussed with regard to equation (2), A_c, D, x₁, x₂and We are all pre-determined or pre-defined known values. In one example, the A_cis the cross-sectional area of theinternal channel152 and in this example, A_c=π(R_c)², wherein R_cis the pre-defined known value of the radius of theinternal channel152. In this example, A_cof theinternal channel152 may be calculated by theprocessor180 based on the known value of R_c, which is received in thehousing data412.
• By having current pass through a givenoutput electrode134a-134j, thebasal monitor module410 determines how far the fluid118 has traveled and, based on equation (3) and thecalibration data258, calculates how much volume of fluid has been delivered per unit time. In this regard, based on thecalibration data258 retrieved with thehousing data412, thebasal monitor module410 compares the determined volume of fluid per period of time from equation (3) with thecalibration data258 and determines the volume of fluid delivered per period of time. Thebasal monitor module410 sets the determined volume delivered per period of time as thebasal rate data240 for the UI control module202 (FIGS. 4A and 4B).
• Based on thebasal rate data240 and therate data228, thebasal monitor module410 determines thebasal error data244. In one example, thebasal monitor module410 determines the basal error data235 based equation (4), below:
• $\begin{array}{cc}{\mathrm{Error}}_i=\left(\frac{\frac{{\mathrm{Vr}}_{i+\frac{P}{S}}-V_{r_i}}{t_{i+\frac{P}{S}}-t_i}-r}{r}\right)*100\%& \left(4\right)\end{array}$
• Wherein Vr_iis the volume at a given data point (i) in cubic millimeters (mm³) as determined from equation (3); t is the time elapsed at the given data point as measured by the timer; P is one hour in seconds (s); S is the data sampling rate of theoutput electrodes134a-134j, which is received from thehousing data412; r is the input basal rate or therate data228 in microliters per hour (μL/h); and Error_iis the overall error value for the dispensing of the fluid by thefluid infusion device102 over the period of time in percent (%). Generally, thebasal rate data240 calculates the Error_ivalue for a plurality of data points over a basal test, and in one example, each data point equal to about one hour of the particular basal test for a 24 hour basal test. Thebasal monitor module410 also determines the maximum error for the basal test, which is the largest calculated Error_ivalue for the basal test. Thebasal monitor module410 determines the minimum error for the basal test, which is the smallest calculated Error_ivalue for the basal test. Thebasal monitor module410 sets the Error_ivalue determined for the data point, along with the maximum error and the minimum error as thebasal rate data240 for the UI control module202 (FIGS. 4A and 4B).
• After determining the volume of fluid delivered per time, thebasal monitor module410 determines whether each of theoutput electrodes134a-134jhas been activated in theinternal channel152 of thetest housing130. If true, thebasal monitor module410 sets thestop command416 for theelectrode control module402. Otherwise, thebasal monitor module410 determines whether theend test command263 has been received as input from theUI control module202. If theend test command263 has been received, thebasal monitor module410 sets thestop command416. Otherwise, thebasal monitor module410 continues to monitor for theactivation data264.
• Referring now toFIG. 10, and with continued reference toFIGS. 1-5, a flowchart illustrates acontrol method500 that can be performed by thetest control system200 ofFIGS. 1-5 in accordance with the present disclosure. In various embodiments, thecontrol method500 is performed by theprocessor180 of thecontroller114. As can be appreciated in light of the disclosure, the order of operation within the method is not limited to the sequential execution as illustrated inFIG. 10, but may be performed in one or more varying orders as applicable and in accordance with the present disclosure. In various embodiments, thecontrol method500 can be scheduled to run based on one or more predetermined events, and/or can run continuously during operation of thetest system100.
• The method begins at502. At504, the method determines whetherinput data210 has been received from the user's manipulation of theinput device108. Ifinput data210 has been received, the method proceeds to506. Otherwise, the method loops.
• At506, the method receives and processes theinput data210 to determine the type of test (test type input data212), the expected pre-defined volumes of fluid that are to be received the particular number of times (fluid quantity input data218), data associated with the particular test device (test device input data214) and the set rate (set rate input data216). At508, the method determines whether the testtype input data212 is a calibration test. If true, the method proceeds to510. Otherwise, at512, the method determines whether the testtype input data212 is a bolus test. If true, the method proceeds to514. Otherwise, at516, the method determines whether the testtype input data212 is a basal test. If true, the method proceeds to518. Otherwise, the method flags an error at520 and ends at522. Optionally, the method may loop from516 to504.
• At510, the method proceeds to start a calibration test, as will be discussed with regard toFIG. 11. With the determination of a bolus test, at514, the method retrieves thecalibration data258 associated with the particular test device (based on the test device input data214) and at524, the method proceeds to start a bolus test, as will be discussed with regard toFIG. 12. With the determination of a basal test, at518, the method retrieves thecalibration data258 associated with the particular test device (based on the test device input data214) and at526, the method proceeds to start a basal test, as will be discussed with regard toFIG. 13.
• Referring now toFIG. 11, and with continued reference toFIGS. 1-5, a flowchart illustrates acalibration method600 that can be performed by thetest control system200 ofFIGS. 1-5 in accordance with the present disclosure. In various embodiments, thecalibration method600 is performed by theprocessor180 of thecontroller114. As can be appreciated in light of the disclosure, the order of operation within the method is not limited to the sequential execution as illustrated inFIG. 11, but may be performed in one or more varying orders as applicable and in accordance with the present disclosure. In various embodiments, thecalibration method600 can be scheduled to run based on one or more predetermined events, such as based on the receipt of theinput data210. Prior to beginning the calibration method, the operator inputs commands to a user interface of thefluid infusion device102 to prime thefluid infusion device102 and thetest housing130.
• The method begins at602. At606, the method commands thepower source112 to apply a voltage to alternating ones of theinput electrodes132a-132jof the fluiddelivery test device106 or outputs thevoltage data262 to thepower source112. At607, the method determines, based on theactivation data264, whether theoutput electrode134aand/or theoutput electrode134bhas been activated such that the voltage applied to theinput electrode132ahas caused current to pass through the fluid118 in theinternal channel152 to therespective output electrode134aand/or134b, which indicates that thetest housing130 has been primed with thefluid118. If theoutput electrodes134aand/or134bare not activated, the method loops until theoutput electrodes134aand/or134bare activated. Otherwise, at609, the method sets a counter to a value equal to zero.
• At608, the method determines, based on theactivation data264, whether one or more of theoutput electrodes134a-134jhave been activated such that the voltage applied to therespective input electrode132a-132jhas caused current to pass through the fluid118 in theinternal channel152 to therespective output electrode134a-134j. If one or more of theoutput electrodes134a-134jare not activated, the method loops until one or more of theoutput electrodes134a-134jare activated.
• If one or more of theoutput electrodes134a-134jare determined to be activated, based on the receipt ofactivation data264, at610, the method determines which of theoutput electrodes134a-134jis activated by the fluid118 flowing within the internal channel152 (FIG. 2). At612, the method determines, based on the current increment of the counter, which pre-defined volume of fluid was received into thetest housing130 based on the testfluid quantity data230 received asinput data210. At614, the method associates the identified pre-defined volume of fluid received into thetest housing130 with the respective one or more of the activatedoutput electrode134a-134jfor theparticular test housing130 identified in thetest device data226, and stores this data as testdevice calibration data268 in thecalibration datastore204.
• At616, the method determines whether each of theoutput electrodes134a-134jin thetest housing130 has been activated based on theactivation data264 that has been received. If true, the method proceeds to618. Otherwise, the method proceeds to620. At620, the method increments the counter by one and loops to608.
• At618, the method commands thepower source112 to cease applying the voltage to alternating ones of theinput electrodes132a-132jof the fluiddelivery test device106 or outputs thestop voltage command270 to thepower source112. The method ends at622.
• Referring now toFIG. 12, and with continued reference toFIGS. 1-5, a flowchart illustrates abolus test method700 that can be performed by thetest control system200 ofFIGS. 1-5 in accordance with the present disclosure. In various embodiments, thebolus test method700 is performed by theprocessor180 of thecontroller114. As can be appreciated in light of the disclosure, the order of operation within the method is not limited to the sequential execution as illustrated inFIG. 12, but may be performed in one or more varying orders as applicable and in accordance with the present disclosure. In various embodiments, thebolus test method700 can be scheduled to run based on one or more predetermined events, such as based on the receipt of theinput data210. Prior to beginning the bolus test method, the operator inputs commands to a user interface of thefluid infusion device102 to prime thefluid infusion device102 and thetest housing130.
• The method begins at702. At704, the method commands thepower source112 to apply a voltage to alternating ones of theinput electrodes132a-132jof the fluiddelivery test device106 or outputs thevoltage data262 to thepower source112. At705, the method determines, based on theactivation data264, whether theoutput electrode134aand/or theoutput electrode134bhas been activated such that the voltage applied to theinput electrode132ahas caused current to pass through the fluid118 in theinternal channel152 to therespective output electrode134aand/or134b, which indicates that thetest housing130 has been primed with thefluid118. If theoutput electrodes134aand/or134bare not activated, the method loops until theoutput electrodes134aand/or134bare activated.
• At706, the method sets a counter to a value equal to zero, and optionally, outputs theprompt user interface257 to instruct the user to dispense the bolus. At707, optionally, the method determines, based on thebolus delivery data217, whether the bolus has been delivered. If true, the method proceeds to708. Otherwise, if false, the method loops.
• At708, the method determines, based on theactivation data264, whether one or more of theoutput electrodes134a-134jhave been activated such that the voltage applied to therespective input electrode132a-132jhas caused current to pass through the fluid118 in theinternal channel152 to therespective output electrode134a-134j. If one or more of theoutput electrodes134a-134jare not activated, the method proceeds to710. At710, the method commands thepower source112 to cease applying the voltage to alternating ones of theinput electrodes132a-132jof the fluiddelivery test device106 or outputs thestop voltage command270 to thepower source112. The method flags an error at712. The method ends at714.
• Otherwise, if one or more of theoutput electrodes134a-134jare determined to be activated, based on the receipt ofactivation data264, at716, the method determines which of theoutput electrodes134a-134jis activated by the fluid118 flowing within the internal channel152 (FIG. 2) and at what time based ontime data266 received from other modules associated with thecontroller114. At718, the method determines, based on the current increment of the counter, which volume of fluid was received into thetest housing130 based on the testfluid quantity data230 received asinput data210. At719, the method associates the identified volume of fluid received into thetest housing130 with the respective one or more of the activatedoutput electrodes134a-134jat the current time for theparticular test housing130 identified in thetest device data226, and stores this data asbolus activation data248 in thebolus datastore404.
• At720, the method determines a volume of fluid delivered by thefluid infusion device102 based on equation (2), thecalibration data258, thetest device data226 and theoutput electrodes134a-134jthat were activated. At722, the method determines thebolus error data236. At724, the method outputs the bolusactivation user interface250 that illustrates when theoutput electrodes134a-134jwere activated at a particular time based on the received fluid or bolus delivered by thefluid infusion device102. At726, the method outputs the bolusamount user interface234 that illustrates the volume of fluid or bolus delivered by thefluid infusion device102 for the particular count of the counter and outputs the boluserror user interface238 that illustrates the error associated with each volume of fluid or bolus delivered by thefluid infusion device102 for the particular count of the counter.
• At728, the method increments the counter by one. At730, the method determines whether the counter is less than the pre-defined threshold count. If the counter is less than the pre-defined threshold count, at732, the method outputs theprompt user interface257 and proceeds to707. Otherwise, if the counter is greater than the pre-defined threshold count, the method proceeds to710.
• Referring now toFIG. 13, and with continued reference toFIGS. 1-5, a flowchart illustrates abasal test method800 that can be performed by thetest control system200 ofFIGS. 1-5 in accordance with the present disclosure. In various embodiments, thebasal test method800 is performed by theprocessor180 of thecontroller114. As can be appreciated in light of the disclosure, the order of operation within the method is not limited to the sequential execution as illustrated inFIG. 13, but may be performed in one or more varying orders as applicable and in accordance with the present disclosure. In various embodiments, thebasal test method800 can be scheduled to run based on one or more predetermined events, such as based on the receipt of theinput data210. Prior to beginning the basal test method, the operator inputs commands to a user interface of thefluid infusion device102 to prime thefluid infusion device102 and thetest housing130.
• The method begins at802. At804, the method commands thepower source112 to apply a voltage to alternating ones of theinput electrodes132a-132jof the fluiddelivery test device106 or outputs thevoltage data262 to thepower source112. At805, the method determines, based on theactivation data264, whether theoutput electrode134aand/or theoutput electrode134bhas been activated such that the voltage applied to theinput electrode132ahas caused current to pass through the fluid118 in theinternal channel152 to therespective output electrode134aand/or134b, which indicates that thetest housing130 has been primed with thefluid118. If theoutput electrodes134aand/or134bare not activated, the method loops until theoutput electrodes134aand/or134bare activated.
• At806, the method sets a timer to a value equal to zero. At808, the method determines, based on theactivation data264, whether one or more of theoutput electrodes134a-134jhave been activated such that the voltage applied to therespective input electrode132a-132jhas caused current to pass through the fluid118 in theinternal channel152 to therespective output electrode134a-134j. If one or more of theoutput electrodes134a-134jare not activated, the method loops.
• Otherwise, if one or more of theoutput electrodes134a-134jare determined to be activated, based on the receipt ofactivation data264, at810, the method determines which of theoutput electrodes134a-134jis activated by the fluid118 flowing within the internal channel152 (FIG. 2) and at what time based ontime data266 received from other modules associated with thecontroller114. At812, the method associates the volume of fluid received into thetest housing130 with the respective one or more of the activatedoutput electrodes134a-134jat the current time of the timer, and stores this data asbasal activation data252 in thebasal datastore408.
• At814, the method determines a volume of fluid delivered by thefluid infusion device102 per time based on equation (3), thecalibration data258, thetest device data226, the value of the timer and theoutput electrodes134a-134jthat were activated. At816, the method determines thebasal error data244 using equation (4). At818, the method outputs the basalactivation user interface254 that illustrates when theoutput electrodes134a-134jwere activated at a particular time based on the fluid delivered by thefluid infusion device102. At820, the method outputs the basalrate user interface242 that illustrates the volume of fluid or bolus delivered by thefluid infusion device102 over the time measured by the timer and outputs the basalerror user interface246 that illustrates the error associated with the amount of fluid received from thefluid infusion device102 over the time measured by the timer.
• At822, the method determines whether each of theoutput electrodes134a-134jin thetest housing130 has been activated based on theactivation data264 that has been received. If true, the method proceeds to824. At824, the method commands thepower source112 to cease applying the voltage to alternating ones of theinput electrodes132a-132jof the fluiddelivery test device106 or outputs thestop voltage command270 to thepower source112. The method ends at826.
• Otherwise, if each of theoutput electrodes134a-134jhave not been activated, the method proceeds to828. At828, the method determines whether theend test data219 has been received in theinput data210. If true, the method proceeds to824. Otherwise, the method loops to808.
• While at least one exemplary embodiment has been presented in the foregoing detailed description, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing the described embodiment or embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope defined by the claims, which includes known equivalents and foreseeable equivalents at the time of filing this patent application.

Claims (20)

What is claimed is:

1. A method for determining a volume of fluid dispensed into a test housing, comprising:

controlling, by a processor, a power source to create a voltage potential across an input electrode arrangement and an output electrode arrangement associated with the input electrode arrangement each coupled to the test housing;

receiving, by the processor, a signal from the output electrode arrangement based on the fluid received into the test housing;

calculating, by the processor, the volume of fluid dispensed into the test housing based on the signal received from the output electrode arrangement;

generating, by the processor, a user interface for display on a display that illustrates the volume of fluid dispensed; and

displaying the generated user interface on the display.

2. The method ofclaim 1, wherein the input electrode arrangement comprises a plurality of input electrodes and the output electrode arrangement comprises a plurality of output electrodes, each one of the plurality of input electrodes associated with a respective at least one of the plurality of output electrodes, and the method further comprises:

controlling, by the processor, the power source to supply a voltage to a respective one of the plurality of input electrodes in a pattern; and

receiving, by the processor, the signal from a respective at least one of the plurality of output electrodes based on the fluid dispensed into the test housing, the signal received based on current conducted from the respective one of the plurality of input electrodes to the respective at least one of the plurality of output electrodes through the fluid dispensed into the test housing.

3. The method ofclaim 2, wherein controlling, by the processor, the power source to supply a voltage to the respective one of the plurality of input electrodes in a pattern further comprises:

controlling, by the processor, the power source to supply the voltage to the respective one of the plurality of input electrodes in a sequential pattern such that one of the plurality of input electrodes receives the voltage at a time.

4. The method ofclaim 2, further comprising:

receiving, by the processor, an input that identifies the test housing;

retrieving, by the processor, test device data associated with the identified test housing, the test device data including at least a dimension associated with an internal channel defined within the test housing and a distance between each one of the plurality of input electrodes; and

calculating, by the processor, the volume of fluid dispensed into the test housing based on the signal received from the respective at least one of the plurality of output electrodes, the dimension associated with the internal channel and the distance between each one of the plurality of input electrodes.

5. The method ofclaim 2, wherein each of the plurality of input electrodes and each of the plurality of output electrodes is in communication with an internal channel defined in the test housing, and the method further comprises:

determining, by the processor, whether an end of the internal channel has been reached based on the signal received from the respective one of the plurality of output electrodes based on the fluid dispensed into the test housing; and

controlling, by the processor, the power source to cease the output of the voltage based on the determining.

6. The method ofclaim 2, wherein the volume of fluid is dispensed by a fluid infusion device into the test housing.

7. The method ofclaim 6, further comprising:

receiving, by the processor, input that provides an expected volume of fluid to be dispensed by the fluid infusion device;

calculating, by the processor, an error associated with the volume of fluid dispensed by the fluid infusion device based on the expected volume of fluid;

generating, by the processor, an error user interface for display on the display that illustrates the error associated with the volume of fluid dispensed by the fluid infusion device; and

displaying the generated error user interface on the display.

8. The method ofclaim 7, wherein the expected volume of fluid to be dispensed by the fluid infusion device is an expected rate of fluid, and the generating, by the processor, the error user interface further comprises:

generating, by the processor, a basal error user interface for display on the display that illustrates the error associated with the volume of fluid dispensed by the fluid infusion device over a period of time; and

displaying the generated basal error user interface on the display.

9. The method ofclaim 6, wherein the volume of fluid to be dispensed by the fluid infusion device is a plurality of discrete boluses of fluid, and the method further comprises:

calculating, by the processor, the discrete boluses of fluid dispensed into the test housing based on the signal received from the respective one of the plurality of output electrodes;

generating, by the processor, a bolus user interface for display on the display that illustrates the discrete boluses of fluid dispensed; and

displaying the generated bolus user interface on the display.

10. The method ofclaim 6, wherein the volume of fluid to be dispensed by the fluid infusion device is a basal rate of fluid, and the method further comprises:

calculating, by the processor, the basal rate of fluid dispensed into the test housing based on the signal received from the respective one of the plurality of output electrodes;

generating, by the processor, a basal rate user interface for display on the display that illustrates the basal rate of fluid dispensed; and

displaying the generated basal rate user interface on the display.

11. The method ofclaim 1, further comprising:

receiving, by the processor, an input to calibrate the test housing;

receiving, by the processor, an input that provides a pre-defined volume of fluid to be dispensed into the test housing;

controlling, by the processor, the power source to supply the voltage to the input electrode arrangement coupled to the test housing;

receiving, by the processor, the signal from the output electrode arrangement based on the pre-defined volume of fluid dispensed into the test housing; and

determining, by the processor, calibration data associated with the test housing based on the signal received from the output electrode arrangement and the pre-defined volume of fluid.

12. A test control system for determining a volume of dispensed fluid, comprising:

a test housing that includes an inlet and an internal channel, the inlet to receive the volume of fluid, and the internal channel in fluid communication with the inlet;

an input electrode arrangement coupled to the test housing;

an output electrode arrangement associated with the input electrode arrangement and coupled to the test housing so as to be spaced apart from the input electrode arrangement; and

a controller, having a processor, that is configured to:

control a power source to supply a voltage to the input electrode arrangement;

receive a signal from the output electrode arrangement based on the fluid received into the test housing;

calculate the volume of fluid dispensed into the test housing based on the signal received from the output electrode arrangement;

generate a user interface for display on a display that illustrates the volume of fluid dispensed; and

display the generated user interface on the display.

13. The test control system ofclaim 12, wherein the input electrode arrangement comprises a plurality of input electrodes and the output electrode arrangement comprises a plurality of output electrodes, each one of the plurality of input electrodes associated with a respective at least one of the plurality of output electrodes, and the processor is configured to:

control the power source to supply the voltage to a respective one of the plurality of input electrodes in a pattern; and

receive the signal from a respective at least one of the plurality of output electrodes based on the fluid dispensed into the test housing.

14. The test control system ofclaim 13, wherein the processor is further configured to:

receive an input that identifies the test housing;

retrieve test device data associated with the identified test housing, the test device data including at least a dimension associated with the internal channel and a distance between each one of the plurality of input electrodes; and

calculate the volume of fluid dispensed into the test housing based on the signal received from the respective one of the plurality of output electrodes, the dimension associated with the internal channel and the distance between each one of the plurality of input electrodes.

15. The test control system ofclaim 13, further comprising a fluid infusion device, wherein the volume of fluid is dispensed by the fluid infusion device into the test housing.

16. The test control system ofclaim 15, wherein the processor is configured to:

receive an input that provides an expected volume of fluid to be dispensed by the fluid infusion device;

calculate an error associated with the volume of fluid dispensed by the fluid infusion device based on the expected volume of fluid;

generate an error user interface for display on the display that illustrates the error associated with the volume of fluid dispensed by the fluid infusion device; and

display the generated error user interface on the display.

17. The test control system ofclaim 16, wherein the expected volume of fluid dispensed by the fluid infusion device is an expected rate of fluid, and the processor is configured to generate a basal error user interface for display on the display that illustrates the error associated with the volume of fluid dispensed by the fluid infusion device over a period of time, and to display the generated basal error user interface on the display.

18. The test control system ofclaim 15, wherein the volume of fluid dispensed by the fluid infusion device is a plurality of discrete boluses of fluid, and the processor is configured to:

calculate the discrete boluses of fluid dispensed into the test housing based on the signal received from the respective one of the plurality of output electrodes;

generate a bolus user interface for display on the display that illustrates the discrete boluses of fluid dispensed; and

display the generated bolus user interface on the display.

19. The test control system ofclaim 15, wherein the volume of fluid dispensed by the fluid infusion device is a basal rate of fluid, and the processor is configured to:

calculate the basal rate of fluid dispensed into the test housing based on the signal received from the respective one of the plurality of output electrodes;

generate a basal rate user interface for display on the display that illustrates the basal rate of fluid dispensed; and

display the generated basal rate user interface on the display.

20. The test control system ofclaim 12, wherein the processor is configured to:

receive an input to calibrate the test housing;

receive an input that provides a pre-defined volume of fluid to be dispensed into the test housing;

control the power source to supply the voltage to the input electrode arrangement coupled to the test housing;

receive the signal from the output electrode arrangement based on the pre-defined volume of fluid dispensed into the test housing; and

determine calibration data associated with the test housing based on the signal received from the output electrode arrangement and the pre-defined volume of fluid.

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