BACKGROUND

This disclosure concerns a method for quality evaluation of a handheld analytical device, specifically a blood glucose meter, wherein the device is operable by a human user in a sequence of handling steps to test an analyte in a sample fluid applied on a test element. This disclosure further concerns a system for quality evaluation of such a handheld or hand-operated analytical device.

A typical operation of a handheld blood glucose meter may include a sequence of handling steps like producing a blood sample by lancing a body part, applying the blood sample onto a disposable test element and measuring the test element in the handheld meter in order to obtain a measurement result on the spot. Such analytical devices are usually operated by patients under various conditions and state of health. Then, the inherent problem exists that a lot of individual variations may influence the reproducibility of the diagnostic test, which make it difficult to investigate and identify possible influencing parameters on the quality of the device. For example, when handheld blood glucose monitoring devices are used, variations may arise from “human factors” such as timing when applying the sample, force exertion, impurities on the skin and so on.

SUMMARY

This disclosure further improves known methods and systems for quality evaluation and provides enhanced reproducibility in “human factor” studies in an efficient way.

This disclosure is based on the idea of using an appropriately programmed robot. Thus, it is proposed according to this disclosure that a method for quality evaluation of a handheld analytical device, specifically a blood glucose meter, comprises the steps of(a) programming a handling cycle for a robot having at least one robot arm in order to mimic a sequence of handling steps of a human user,(b) operating the device in at least one handling cycle by means of the robot,(c) monitoring the operation in step (b) by a control unit to evaluate at least one parameter influencing the quality of the device.

Thereby it is possible to investigate different test scenarios in a defined manner and to identify the influences of possible flawed human interactions on the final measurement result. In particular, by providing an automated handling cycle for the robot to be carried out with specific commands, actions and/or steps to closely imitate or mimic a user behavior, standardized and highly reproducible human factor studies are enabled.

Advantageously, monitoring the operation of the device comprises obtaining a test result with the device. Thus, inspection results can be achieved in a realistic and efficient way.

Another improvement in this connection provides that evaluating a parameter influencing the quality of the device comprises determining a measurement accuracy of the device.

It is also preferred that an operating condition of the robot is modified in a plurality of handling cycles in order to identify an influence on the quality or accuracy of the device.

A further preferred embodiment comprises adapting or modifying one or more handling cycles to simulate differences in user handling and evaluating an influencing parameter resulting therefrom.

In particular, it is advantageous by adapting or modifying one or more handling cycles to account for any forms of deviant user handling which is due to or derived from an impairment or illness of the user. Specifically, an impairment of perception and cognitive abilities or an illness such as a tremor, trembling or shaking (e.g. in connection with diseases like Parkinson or Alzheimer) may be accounted for.

In this connection, it is also advantageous to reproduce a user's impairment or illness by adapting the handling cycle in a number of degrees of freedom of the robot movement, e.g. in spatial direction, amplitude, velocity and frequency of an oscillation or deflection of the robot (arm and/or artificial finger).

According to a particularly preferred embodiment, an artificial finger on the robot arm is used to apply sample fluid to a test element, specifically whole blood or artificial blood. The use of such an artificial finger enables mimicking of various factors of the user handling of a handheld analytical device such as a blood glucose meter very close to reality.

Preferably, the handling cycle comprises moving the artificial finger with a predefined orientation and/or force towards a test element. Such movements can be carried out by the robot with high precision and a maximum of repeat accuracy.

In order to simulate the sampling of blood, the handling cycle preferably comprises loading the artificial finger with sample fluid by means of a fluid supply arranged within the artificial finger or by means of a pipette.

For further improvement of the inspection procedure it is advantageous when the artificial finger is provided with a property similar to a human finger, in particular at least one of a predefined elasticity, skin friction, surface contamination and color.

For imitation of human manipulation of a handheld instrument, the handling cycle preferably comprises grabbing the device with a free receiving end of the robot arm.

Another improvement in this direction is achieved when the robot is provided with one or two robot arms and the handling cycle provides for simulation of at least one of right-handed, left-handed, single-handed and two-handed use of the device.

In order to allow complex and highly precise handling operations, it is preferred to make each robot arm rotatable around at least five different axes provided in articulated joints distributed along the length of the robot arm.

According to a particular embodiment the handling cycle comprises continuously carrying the device by the robot arm or depositing the device intermittently within the reach of the robot arm.

According to a further preferred implementation, a graphical user interface is used for simplified programming of the handling cycle as a chain of preprogrammed modules which define elementary movements of the robot. This allows establishing, by way of combining graphical symbols which represent the preprogrammed modules, a robotically guided inspection procedure even for personnel without profound knowledge in the field of robotics.

A further improvement in this direction is that movement paths of the robot can be modified by re-arranging graphical symbols on a display which represent the preprogrammed modules.

A still further improvement comprises simulating the handling cycle by running the chain of modules on a computer system separate from the robot.

Another aspect of this disclosure concerns a system for quality evaluation of a handheld analytical device, specifically a blood glucose meter, which is operable by a human user in a sequence of handling steps to test an analyte in a sample fluid applied on a test element, the system further comprising a robot which is programmed to mimic the sequence of handling steps in an automated handling cycle, and a control unit adapted for monitoring operation of the device in one or more handling cycles to evaluate at least one parameter influencing the quality of the device. Such a system allows carrying out the method as described above and simulating patient behavior close to reality in human factor studies.

