RR Mechatronics STARRSED RS, User Manual

Page: 126 / 259

When the result is out of range an error message is shown in the status line of the Sample screen and the
QC icon is blinking on the Sample screen. When the sample mode is started again by the operator, the
following messages appears:
Last QC result was out of range! Continuing could produce incorrect results! Do you still want to
continue?
Press "Accept" to continue sampling without performing a new QC, press "Cancel" to return and take
appropriate action.
Messages when the general setting "Temperature Correction" is switched ON:
• "E116: QC is out of acceptable range!"
The Sample mode is switched OFF automatically. Remaining filled pipettes are processed in the normal
manner.
Messages when the general setting "Temperature Correction" is switched OFF:
The software always calculates a temperature corrected result because only temperature corrected results
can be compared with the Assay mean value.
• "E116: QC is out of acceptable range!"
The uncorrected and the corrected result are out of range.
• "E117: Uncorrected QC result is out of acceptable range, but corrected result is within range!"
The uncorrected result is out of range, but the corrected result is within range.
• "E118: Uncorrected QC result is within acceptable range, but corrected result is out of range!"
The uncorrected result is within range, but the corrected result is out of range.
See Quality control troubleshooting and QC Results screen for more details.
10.2.6.2 - QC Result analysis
Authorized staff should identify and differentiate acceptable/unacceptable random errors and trends and/or
shifts in systematic errors from the statistical data. Depending on the users Quality Control Procedures
analytical results could be accepted or rejected.
Changes in QC results can be gradual or abrupt. Gradual changes can be caused by contamination and
incidental environmental variations. Abrupt changes can be caused by change of QC material batch or
possible hardware errors.
If results are continuously out of range due to significant difference between calculated mean and control
value, but the statistics show precise results with small deviations, it should be considered to expand the
acceptable assay range with QC Settings .
If results are incidentally out of range it is advised to perform a daily maintenance and/or fill and clean step
and then perform another QC sample step before releasing patient results.
If results are not sent to the LIMS QC Results can be exported to MS Excel CSV files for further analysis in
lab's own Quality Control data system.
Quality control
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MRN-071-2-EN version 7.02 Starrsed RS