Analyte test instrument having improved calibration and communication processes

• US 20020082797A1
• Filed: 12/14/2001
• Published: 06/27/2002
• Est. Priority Date: 11/30/1998
• Status: Active Grant

• Current Assignee: Joel M. Parks, Leonidas Carayannopoulos, Marshall D. Deweese, William H. Ames
• Original Assignee: Joel M. Parks, Leonidas Carayannopoulos, Marshall D. Deweese, William H. Ames
• Inventors: Ames, William H., Deweese, Marshall D., Carayannopoulos, Leonidas, Parks, Joel M.
• Granted Patent: US 6,600,997 B2
• Time in Patent Office: Days
• US Class Current: 702/122
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G05B 2219/24038 Several test signals stored in memory and used as input signals

Abstract

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

Claims

1. A method for calibrating an analyte test instrument having a test port adapted to receive any one of a plurality of data storage strips, a processor electrically connected to the test port, and a memory storing a protocol for communication with each data storage strip, said method comprising the steps of:

(a) receiving into said test port a data storage strip;

(b) polling said test port to identify said data storage strip; and

(c) establishing communications with said data storage strip using a protocol corresponding to said data storage strip.

2. The method of claim 1, wherein said data storage strip comprises a memory device.

3. The method of claim 1, further comprising the steps of:

(d) downloading data from said data storage strip into said analyte test instrument; and

(e) storing said downloaded data in said memory.

4. The method of claim 3, wherein said data comprises instrument parameters, test strip parameters, and analyte parameters.

5. The method of claim 4, wherein said instrument parameters include language and meter type.

6. The method of claim 4, wherein said test strip parameters include test strip count and expiration date.

7. The method of claim 3, further comprising the step of:

(f) removing said data storage device from said test port.

8. The method of claim 3, further comprising the steps of:

(g) inserting a test strip into said test port; and

(h) implementing a test procedure using said downloaded data.

9. A method for operating an analyte test instrument having a test port adapted to receive a test strip or a calibration strip, a processor electrically connected to said test port, and a display for displaying information, said method comprising the steps of:

(a) receiving a test strip into said test port;

(b) accessing test parameters stored in a memory;

(c) determining whether one or more of said test parameters is invalid for said test strip; and

(d) displaying an indication of the invalid strip parameter on said display.

10. The method of claim 9, wherein said test parameters include test strip count and expiration date.

11. The method of claim 10, further comprising the step of:

(e) disabling the analyte test in the instrument when said expiration date has passed.

12. The method of claim 10, further comprising the step of:

(e) displaying a warning on said display when said strip count has been exceeded.

13. The method of claim 9, wherein said test parameters include instrument language and instrument type.

14. The method of claim 13, further comprising the step of:

(e) disabling the analyte test in said instrument when said instrument language and said instrument type is invalid.

15. The method of claim 9, wherein said strip is a calibration strip or a test strip.

16. The method of claim 15, wherein said calibration strip comprises a data storage device and step (a) further comprises the steps of:

(e) downloading data from the calibration strip into the analyte test instrument; and

(f) storing the downloaded data in memory.

17. The method of claim 9, wherein the indication displayed comprises an error message, a warning message, or an instruction message.

19. The method of claim 18, wherein step (c) further comprises the steps of:

(i) establishing communications between an external device and said analyte test instrument; and

(ii) downloading said reference date and time from said external device to said analyte test instrument.

20. The method of claim 18, wherein said analyte test instrument comprises a user interface step (c) further comprises the step of entering said reference date and time into said analyte test instrument using said user interface.

21. The method of claim 18, wherein said analyte test instrument is battery operated.

22. The method of claim 21, wherein said step of assigning a value to each event comprises assigning a value to each event when such event is stored in memory and battery operation of said instrument has been interrupted.

24. The method of claim 23, wherein the step of downloading the data further comprises the step of downloading at least a portion of a test procedure that said analyte test instrument uses to conduct diagnostic tests.

25. The method of claim 25, further comprising the steps of:

(g) storing, on the analyte test instrument, a plurality of test procedures used to conduct one or more diagnostic tests using said analyte test instrument; and

(h) downloading a control procedure from said data storage strip that selects one or more of said stored procedures to run.

18. A method for determining the actual date and time of events in an analyte test instrument, said method comprising the steps of:

(a) storing events generated by operation of said analyte test instrument in memory;

(b) assigning a time-relative value to each event when such event is stored in memory;

(c) providing a reference date and time to said analyte test instrument; and

(d) assigning a reference value to said reference date and time; and

(e) computing said actual date and time of each event by adjusting the value assigned to each event using said reference value.

23. A method for controlling the operation of an analyte test instrument having a test port adapted to receive any one of a plurality of data storage strips, a processor electrically connected to the test port, and a memory storing a protocol for communication with each data storage strip, said method comprising the steps of:

(a) receiving into said test port a data storage strip;

(b) polling said test port to identify said data storage strip; and

(c) establishing communications with said data storage strip using a protocol corresponding to said data storage strip;

(d) downloading data from said data storage strip into said analyte test instrument;

(e) storing said downloaded data in said memory; and

(f) removing said data storage device from said test port.