Abbott ALERE AFINION AS100 Manuel D'utilisation page 27

Running controls with enabled QC lockout function
When running controls with the QC lockout function enabled, the Afinion Control Data is required to be entered or previously
stored in the instrument control lot database. See "QC lockout configuration", page 17.
1) The Afinion Control Data is entered before, during or after the control run. If a barcode scanner is connected (recommended) the
Control Data barcode may be scanned. The control lot will automatically be stored in the instrument control database.
2) If the Afinion Control Data is previously stored in the instrument control database, the operator will simply need to enter the
8 digit control lot number before, during or after the control run.
If the instrument is configured to QC lockout and the control lot number is not found in the Afinion control database or the Afinion
Control Data entered is not valid, the instrument will present an option to retry the input or discard the control run result. If discarded,
the result will not be stored in the instrument result records.
Passed
The result of the control is checked against the acceptable ranges for the corresponding lot number.
If the result is within the limits, a pass symbol
according to the QC lockout configuration.
If QC lockout is configured to require two control levels (C I and C II), both levels must pass to reset the
lockout interval. Only the interval for the control level used in the test is reset.
Failed (above or below the acceptable control range)
When a control result is not within the acceptable ranges specified for the control lot, a failed symbol
is shown on the screen. The result is stored in the instrument and is sent to the data management system
if connected. The QC lockout interval will not be reset.
The arrow symbol will specify whether the result is above
See "Handling and testing controls", page 18.
is displayed on the screen and the QC lock interval is reset
or below the acceptable ranges.
Testing Procedures
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