Calibration data entry system for a test instrument

• US 20040142483A1
• Filed: 01/02/2004
• Published: 07/22/2004
• Est. Priority Date: 01/21/2003
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Genshaw, Marvin A.
• Granted Patent: US 7,212,925 B2
• Time in Patent Office: Days
• US Class Current: 436/164
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G01D 18/006 Intermittent recalibration
• CPC Class Codes: G01D 18/008 with calibration coefficients stored in memory
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001

Abstract

A test device for determining the concentration of an analyte in body fluid is disclosed according to one embodiment of the present invention. The test device has a memory in which a plurality of calibration adjustments corresponding to a plurality of calibration numbers are stored. The test device is adapted to receive a test sensor for collecting a sample, wherein the test sensor contains a reagent adapted to produce a reaction indicative of the concentration of the analyte in the sample and the test sensor has an associated calibration number of a plurality of digits. The test device comprises a measuring unit, a single calibration input element, a user display, and a processor electronically coupled to the single calibration input element, the measuring unit, and the user display. The measuring unit measures the reaction of the reagent and the analyte and generates a signal indicative of the measured reaction. The single calibration input element permits a user to input the calibration number, one digit at a time, associated with the test sensor. The a processor is adapted to determine the concentration of the analyte in the sample in response to receiving the inputted calibration number and receiving the signal indicative of the measured reaction from the measuring unit. The user display displays digits to be selected from by a user inputting the calibration number and displays the determined concentration of the analyte in the sample.

Claims

1. A test device for determining the concentration of an analyte in a sample, the test device having a memory in which a plurality of calibration adjustments corresponding to a plurality of calibration numbers are stored, the test device being adapted to receive a test sensor for collecting the sample, the test sensor containing a reagent adapted to produce a reaction indicative of the concentration of the analyte in the body fluid, the test sensor having an associated calibration number of a plurality of digits, the device comprising:

a measuring unit for measuring the reaction of the reagent and the analyte and for generating a signal indicative of the measured reaction;

a single calibration input element for permitting a user to input the calibration number, one digit at a time, associated with the test sensor;

a processor electronically coupled to the single calibration input element and the measuring unit, the processor being adapted to determine the concentration of the analyte in the sample in response to receiving the inputted calibration number and receiving the signal indicative of the measured reaction from the measuring unit; and

a user display electronically coupled to the processor for displaying digits to be selected from by a user inputting the calibration number and for displaying the determined concentration of the analyte in the sample.

2. The device of claim 1 wherein the calibration number includes a first digit and a second digit, the processor being adapted to commence scrolling through a plurality of numbers on the user display, from which the first digit of the calibration number is selected, upon activation of the single calibration input element by the user, the processor being adapted to suspend scrolling through the numbers upon deactivation of the single calibration input element by the user, the processor accepting the number displayed on the user display at the time of the deactivation of the single calibration input element as the first digit of the calibration number.

3. The device of claim 2 wherein the processor accepts the displayed number after a predetermined time period measured from the deactivation of the single calibration input element.

4. The device of claim 2 wherein the processor is adapted to commence scrolling through a plurality of numbers on the user display, from which the second digit of the calibration number is selected, upon activation of the single calibration input element by the user after acceptance by the processor of the first digit of the calibration number, the processor being adapted to suspend scrolling through the numbers upon deactivation of the single calibration input element by the user, the processor accepting the number displayed on the user display at the time of the deactivation of the single calibration input element as the second digit of the calibration number.

5. The device of claim 1 wherein the processor prompts the user, via the display, to input a first digit of the calibration number.

6. The device of claim 5 wherein the processor is adapted to scroll through a plurality of numbers on the user display, from which the first digit of the calibration number is selected, in response to a plurality of activations of the single calibration input element by the user, the processor accepting a displayed number as the first digit of the calibration number after a predetermined time measured from a most-recent activation of the single calibration input element.

7. The device of claim 6 wherein the processor prompts the user, via the display, to input a second digit of the calibration number upon acceptance of the first digit.

8. The device of claim 7 wherein the processor is adapted to scroll through a plurality of numbers on the user display, from which the second digit of the calibration number is selected, in response to a plurality of activations of the single calibration input element by the user, the processor accepting a displayed number as the second digit of the calibration number after a predetermined time measured from the last activation of the single calibration input element.

9. The device of claim 8 wherein the calibration number consists of a predetermined number of digits, the processor automatically adjusting the at least one adjustable parameter of the concentration equation upon receipt of the final digit of the calibration number consisting of a predetermined number of digits.

10. The device of claims 8 further comprising an enter input element for permitting a user to indicating to the processor that all of digits of the calibration number have been entered, the processor automatically adjusting the at least one adjustable parameter of the concentration equation upon activation of the enter input element by the user.

11. The device of claim 1 wherein the calibration number consists of a predetermined number of digits, the processor adjusting the at least one adjustable parameter of the concentration equation according to the stored adjustment corresponding to the input calibration number upon receipt of each of the predetermined number of digits of the calibration number.

12. The device of claim 1 further comprising an enter input element, the processor accepting the inputted calibration number upon receipt user input, via the enter input element, indicating that each of the plurality of digits of the predetermined number have been input.

13. The device of claim 1 wherein the calibration number ranges between two digits and five digits.

14. The device of claim 1 wherein the calibration number has a number base selected from the group consisting of number base three, number base four, number base five, and number base six.

15. The device of claim 1 wherein the processor is adapted to display on the user display a previously entered calibration number upon an initial activation of the single calibration input element.

16. The device of claim 1 wherein the reagent is adapted to produce an optical reaction and the measuring unit is adapted to measure the optical reaction.

17. The device of claim 16 wherein the optical reaction is a colorimetric reaction and the measuring unit is adapted to measure the calorimetric reaction.

18. The device of claim 1 wherein the reagent is adapted to produce an electrochemical reaction and the measuring unit is adapted to measure the electrochemical reaction.

19. The device of claim 1 wherein the sample is blood.

20. The device of claim 1 wherein the analyte is glucose.

21. The device of claim 1 wherein the processor determines the concentration of the analyte in the sample according to a calibration equation having an adjustable parameter, the processor adjusts the adjustable parameter according to the stored adjustment corresponding to the inputted calibration number.

22. A method for entering a multiple-digit calibration number into a test device, the test device having a memory in which a plurality of calibration adjustments corresponding to a plurality of calibration numbers are stored, the test device being adapted to receive a test sensor for collecting a sample, the test sensor containing a reagent adapted to produce a reaction indicative of the concentration of the analyte in the sample, the test sensor having an associated calibration number, the method comprising:

prompting a user, via a user display, to enter a digit of the calibration number;

receiving input from the user, via a single calibration input element, indicative of the calibration number, one digit at a time;

measuring the reaction of between an analyte in a collected body fluid sample and the reagent contained in the test sensor;

determining the concentration of the analyte in the body fluid in response to receiving the calibration number from the user and measuring the reaction; and

displaying the determined concentration of the analyte in the body fluid on the user display.

23. The method of claim 22 wherein receiving input from the user indicative of the calibration number further comprises:

(a) prompting the user to input a particular one of the multiple digits of the calibration number;

(b) scrolling through a plurality of digits, one at a time, from which the particular one of the multiple digits can be selected, on the user display in response to repeated activations of the single calibration input element by the user until a displayed number is displayed on the user display;

(c) accepting the displayed number as the particular one of the multiple-digits of the calibration number; and

(d) repeating (a) through (c) until all of the digits of the multiple-digit calibration number have been accepted.

24. The method of claim 23 wherein the accepted digits are accepted by the test device as the calibration number after a predetermined time period of inactivity.

25. The method of claim 23 wherein the accepted digits are accepted by the test device as the calibration number upon receipt of user input, via an enter input element, indicative that the all of the digits of the calibration number have been inputted by the user.

26. The method of claim 23 wherein scrolling through a plurality of numbers comprises scrolling through the numbers corresponding to the number base of the calibration number.

27. The method of claim 22 wherein receiving input from the user indicative of the calibration number further comprises:

(a) prompting the user to input a particular one of the multiple digits of the calibration number;

(b) scrolling through a plurality of numbers displayed on the user display, from which the particular one of the multiple digits can be selected, in response to activating the single calibration input element;

(c) suspending the scrolling when a desired number for selection as the particular one of the multiple digits is displayed on the user display in response to deactivating the single calibration input element;

(d) accepting the displayed number as the particular one of the multiple-digits of the calibration number; and

(e) repeating (a) through (d) until all of the digits of the multiple-digit calibration number have been accepted.

28. The method of claim 27 wherein the accepted digits are accepted by the test device as the calibration number after a predetermined time period of inactivity.

29. The method of claim 27 wherein the accepted digits are accepted by the test device as the calibration number upon receipt of user input, via an enter input element, indicative that the all of the digits of the calibration number have been inputted by the user.

30. The method of claim 27 wherein scrolling through a plurality of numbers comprises scrolling through the numbers corresponding to the number base of the calibration number.

31. The method of claim 22 wherein the multiple-digit calibration ranges between two digits and five digits.

32. The method of claim 22 wherein the calibration number has a number base selected from the group consisting of number base three, number base four, number base five, and number base six.

33. The method of claim. 22 wherein measuring comprises measuring an optical reaction.

34. The method of claim 22 wherein measuring comprises measuring a colorimetric reaction.

35. The method of claim 22 wherein measuring comprises measuring an electrochemical reaction.

36. The method of claim 22 wherein the sample is blood.

37. The method of claim 22 wherein the analyte is glucose.

38. The method of claim 22 wherein determining comprises determining the concentration of the analyte in the sample according to a calibration equation having an adjustable parameter and adjusting the adjustable parameter according to the stored adjustment corresponding to the inputted calibration number.

39. A calibration number input system for a test device for measuring the concentration of an analyte in a sample, the test device having a memory in which a concentration equation having at least one adjustable parameter and a plurality of calibration adjustments for the concentration equation corresponding to a plurality of calibration numbers are stored, the input system comprising:

a user display for displaying information to a user of the test device;

a single calibration input element for permitting the user to select digits for inputting a multiple-digit calibration number, one digit at a time; and

a processor electronically coupled to the single calibration input element and the user display, the processor prompting the user to input each of the digits of the calibration number, one at a time, the processor receiving the inputted calibration number and adjusting the at least one adjustable parameter of the concentration equation according to the stored adjustment corresponding to the inputted calibration number.

40. The system of claim 39 wherein the processor is adapted to receive a calibration number of a specific number of digits, the processor permitting a user to scroll through an array of numbers being displayed on the user display, one number at a time, such that the next number in the array of numbers to be displayed is displayed in response to each activation of the single calibration input element, each digit of the calibration number being selected from the array of numbers, the processor accepting a displayed number as the particular digit of the calibration number presently being inputted by the user in response to not receiving input from the single calibration input element for a predetermined time period, the processor entering the accepted numbers as the calibration number upon acceptance of a number as a last number of the specific number of digits.

41. The system of claim 39 wherein the processor prompts the user, via the display, to input a first digit of the calibration number upon an initial activation of the single calibration input element.

42. The system of claim 39 wherein the calibration number ranges between two digits and five digits.

43. The system of claim 39 wherein the calibration number has a number base selected from the group consisting of number base three, number base four, number base five, and number base six.

44. The system of claim 39 wherein the numbers in the array of numbers corresponds to the number base of the calibration number.

45. The system of claim 39 wherein the processor is adapted to display on the user display a previously entered calibration number upon an initial activation of the single calibration input element.

46. The system of claim 45 wherein the processor is adapted to enter the displayed previously entered calibration number as the calibration number to be used after a predetermined time period has elapsed measured from the initial activation of the single calibration input element during which the single calibration input element is not activated.