Data processing: measuring – calibrating – or testing – Calibration or correction system – Error due to component compatibility
Reexamination Certificate
1998-04-06
2001-06-12
Shah, Kamini (Department: 2857)
Data processing: measuring, calibrating, or testing
Calibration or correction system
Error due to component compatibility
C600S368000
Reexamination Certificate
active
06246966
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to a clinical analyzer, and, more particularly, to a new and improved method and apparatus for data management authentication in a clinical analyzer.
DESCRIPTION OF THE PRIOR ART
The quantitative determination of analytes in body fluids is of great importance in the diagnoses and maintenance of certain physiological abnormalities. For example lactate, cholesterol and bilirubin should be monitored in certain individuals. In particular, the determination of glucose in body fluids is of great importance to diabetic individuals who must frequently check the level of glucose in their body fluids as a means of regulating the glucose intake in their diets. While the remainder of the disclosure herein will be directed towards the determination of glucose, it is to be understood that the procedure and apparatus of this invention can be used with other diagnostic systems.
Diagnostic systems, such as, blood glucose systems include a biosensor used to calculate the actual glucose value based on a measured output (either current or color) and the known reactivity of the reagent sensing element used to perform the test. The test results typically are displayed to the user and stored in a memory in the blood glucose monitor. It is desirable to periodically transfer the multiple stored values from the blood glucose monitor to a separate computer, for example to enable analysis by a doctor for the blood glucose monitor user.
One known communications protocol for such data transfer is the ASTM Standard E1381-91, “Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Meters and Computer Systems” and ASTM Standard E1394-91, “Standard Specifications for Transferring Information Between Clinical Meters and Computer Systems”. ASTM Standard E1381-91 defines the low-level data transfer protocol and ASTM Standard E1394-91 defines the data format.
Multiple commercially available clinical analyzer are available for patient use. Due to differences between various commercially available clinical analyzer, a need exists for a method and apparatus for data management authentication in a clinical analyzer to validate data transmissions and to identify a particular type of clinical analyzer. Otherwise if a patient changes to a different type of clinical analyzer, then analysis by the patient's doctor of the data transfers from the different clinical analyzer likely would provide erroneous results.
SUMMARY OF THE INVENTION
Important objects of the present invention are to provide a new and improved method and apparatus for data management authentication in a clinical analyzer; to provide such method and apparatus that eliminates or minimizes the need for user interaction; and to provide such method and apparatus that overcome some disadvantages of prior art arrangements.
In brief, a method and apparatus are provided for data management authentication in a clinical analyzer. The clinical analyzer includes a sensor for receiving a user sample to be measured and a processor for performing a predefined test sequence for measuring a predefined parameter value. A memory is coupled to the processor for storing predefined parameter data values. An authentication password is associated with each data transmission by the clinical analyzer to an associated computer system. The authentication password is read by the associated computer system to validate each data transmission. The authentication password is generated by the clinical analyzer utilizing predetermined information in each data transmission.
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Bayer Corporation
Jeffers Jerome L.
Raymond Edward
Shah Kamini
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