HANDHELD ANALYZER FOR TESTING A SAMPLE

• US 20090298182A1
• Filed: 06/02/2008
• Published: 12/03/2009
• Est. Priority Date: 06/02/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Schulat, Jochen, Albrecht, Gertrud, Kern, Bernhard
• Granted Patent: US 8,394,637 B2
• Time in Patent Office: Days
• US Class Current: 436/63
• CPC Class Codes: G01N 33/48757 Test elements dispensed from a stack
• CPC Class Codes: Y10T 436/110833 Utilizing a moving indicator strip or tape
• CPC Class Codes: Y10T 436/114165 with step of insertion or removal from test line
• CPC Class Codes: Y10T 436/115831 Condition or time responsive
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

The invention relates to a handheld analyzer for testing a sample, in particular of a biological fluid, for a medically significant component. It comprises a test unit, which detects the correct positioning of an analytical consumable means in a conveyance pathway. According to this invention, the test unit has both an electric switch component which mechanically senses the positioning of the analytical consumable means and an optical sensor unit which optically senses the positioning of the analytical consumable means on the conveyance pathway. The handheld analyzer is controlled as a function of a comparison of the signals of the electric switch component and the optical sensor unit. It is possible in this way to reduce malfunctions or operating errors associated therewith.

Claims

1. A handheld analyzer for testing a biological fluid for a medically significant component, comprising a display device, a housing, a loading opening for receiving a replaceable magazine containing a plurality of analytical consumable means, a withdrawal device for withdrawing one of the analytical consumable means from the magazine and for conveying it onto a conveyance pathway, an analysis sensor to which an analytical consumable means may be supplied on the conveyance pathway, and a test unit which detects the correct positioning of an analytical consumable means in the conveyance pathway, wherein the test unit comprises an electric switch component configured for mechanically sensing the positioning of an analytical consumable means on the conveyance pathway, assuming at least one switch position which represents the presence of an analytical consumable means and delivering a switch signal as a function of the positioning of the analytical consumable means, the test unit further comprising an optical sensor unit configured for optically sensing the positioning of an analytical consumable means on the conveyance pathway and delivering a sensor signal as a function of the positioning of the analytical consumable means, and the test unit further comprising a control unit configured for analyzing the switch signal of the electric switch component, analyzing the sensor signal of the optical sensor unit, and controlling the handheld analyzer as a function of the comparison of these signals.

2. The handheld analyzer according to claim 1, wherein the replaceable magazine comprises a rotary drum magazine, and wherein the plurality of analytical consumable means comprise a plurality of test strips.

3. The handheld analyzer according to claim 1, wherein the electric switch component comprises a displaceable peg as a switch element with a conically tapering end facing the analytical consumable means, and wherein each of the analytical consumable means comprises at least one of an elevation or recess corresponding to the conically tapering end of the peg as a position-specific surface design.

4. The handheld analyzer according to claim 3, wherein the displaceable peg is spring-mounted.

5. The handheld analyzer according to claim 3, wherein the position-specific surface design comprises a contour configured to influence the deflection of the peg depending on the position of the analytical consumable means in the conveyance pathway, the contour being selected from the group consisting of a channel that varies with at least one of width or depth, and a ramp that varies with at least one of width or height.

6. The handheld analyzer according to claim 1 wherein the electric switch component comprises a switch element and the optical sensor unit is configured for determining the position of the switch element.

7. The handheld analyzer according to claim 6 wherein the switch element comprises a displaceable peg.

8. The handheld analyzer according to claim 1, wherein the optical sensor unit is configured for determining one of the presence or position of the analytical consumable means on the basis of its reflective or transmitting optical properties.

9. The handheld analyzer according to claim 1, wherein the optical sensor unit forms a joint sensor unit together with the analysis sensor.

10. The handheld analyzer according to claim 1, wherein the withdrawal of an analytical consumable means from the magazine by the withdrawal device is prevented by the control unit when either the switch signal of the electric switch component or the sensor signal of the optical sensor unit represents the correct positioning and the respective other signal represents the incorrect positioning of an analytical consumable means on the conveyance pathway.

11. The handheld analyzer according to claim 10 wherein an error message is output on the display device when the withdrawal of an analytical consumable means is prevented by the control unit.

12. The handheld analyzer according to claim 1, wherein the analysis sensor is configured to be activated to test a sample for a medically significant component when the correct positioning of an analytical consumable means in the conveyance pathway has been detected by means of a switch signal of the electric switch component which represents the correct positioning of an analytical consumable means.

13. The handheld analyzer according to claim 1, wherein the optical sensor unit is configured to be activated for at least one of checking or verifying the switch signal of the electric switch component only when the switch signal of the electric switch component indicates that there is no analytical consumable means in the correct position on the conveyance pathway.

14. A method for operating a handheld analyzer for testing a biological fluid for a medically significant component, the method comprising the steps of:

providing the handheld analyzer comprising a display device, a withdrawal device, for withdrawing an analytical consumable means from a magazine and for conveying said means onto a conveyance pathway, an analysis sensor to which the analytical consumable means can be supplied on the conveyance pathway, and a test unit comprising an electric switch component, an optical sensor unit and a control unit, the test unit being configured to detect the correct positioning of an analytical consumable means in the conveyance pathway;

activating the handheld analyzer;

withdrawing, one of the analytical consumable means from the magazine and conveying said means onto the conveyance pathway;

analyzing a switch signal from the electric switch component using the control unit, the electric switch component being configured for mechanically sensing the positioning of an analytical consumable means on the conveyance pathway;

analyzing a sensor signal from the optical sensor unit using the control unit, the optical sensor unit being configured for optically sensing the positioning of the analytical consumable means on the conveyance pathway; and

controlling the handheld analyzer as a function of the comparison of the switch signal and the sensor signal.

15. The method for operating a handheld analyzer according to claim 14, further comprising the step of releasing the analysis sensor for performing a measurement operation for testing the sample for a medically significant component when correct positioning by the electric switch component has been signaled.

16. The method for operating a handheld analyzer according to claim 14, further comprising the step of activating the optical sensor unit for at least one of checking or verifying the switch signal only when the switch signal indicates that there is no analytical consumable means in the correct position on the conveyances pathway.

17. The method for operating a handheld analyzer according to claim 14, further comprising the step of activating the optical sensor unit for at least one of checking or verifying the switch signal when the withdrawal device has been activated but the switch signal indicates that there is no analytical consumable means in the correct position on the conveyance pathway.

18. The method for operating a handheld analyzer according to claim 14, further comprising the steps of suppressing the withdrawal of an analytical consumable means by the withdrawal device when one of the switch signal or the sensor signal represents the correct positioning of the analytical consumable means and the other respective signal indicates incorrect positioning of the analytical consumable means, and outputting an error message on the display device.

19. The method for operating a handheld analyzer according to claim 14, further comprising the step of activating the withdrawal device when the electric switch component detects that the positioning of the analytical consumable means is not correct and the incorrect positioning is confirmed by the optical sensor unit.

20. The method for operating a handheld analyzer according to claim 19, further comprising the steps of preventing further activation of the withdrawal device when complete emptying of the magazine has been detected, and outputting an error message on the display device.