Abbott ALERE AFINION AS100 Manuel D'utilisation page 26

Testing Procedures
Using the QC lockout function
When the QC lockout function is enabled for one or more assays, approved control testing is required within the configured interval.
If the interval expires, patient testing for the assay will be locked. A passed control run must be performed according to configuration
to reset the interval or to unlock the assay for patient testing. A failed control run will disable patient testing (see "QC lockout
configuration", page 17).
QC lockout status
The status of the active QC lockouts is presented with a QC lockout status button (padlock symbol) visible in the Start-up menu.
This gives the operator the status of QC lockout before he attempts to run any tests.
The padlock symbol will only be visible if QC lockout function is enabled for one or more assay types.
The padlock symbols used are:
1
Enabled-unlocked
All controls are within the configured interval. It is possible to run patient tests for all assays.
2
Warning-unlocked
All controls are within the configured interval. When one or more of the assays has 10 % or less of the
configured interval remaining the warning icon will be displayed. It is possible to run patient tests for all assays.
3
Expired-locked
One or more controls have expired according to the configured interval. Patient testing on the expired
assay has been locked.
Touch the QC lockout status button (padlock symbol) in the Start-up menu to enter the QC lockout status view.
Status
The information is displayed as a list.
Only the assays with QC lockout activated are displayed in this window.
Red text indicates expired assays and orange text indicates assays within warning period.
Control level
How to reset QC lock interval and/or unlock expired assays.
4
If no control level is specified, it is required to run one passed control, control level C I or C II, to reset the QC
lockout interval and unlock the assay for patient testing.
E.g.
HbA1c: #0
If the control level is specified it is required to run two passed controls, both control level C I and C II, to reset
the QC lockout interval and unlock the assay for patient testing.
E.g.
ACR C I: 00.00.00
ACR C II: 00.00.00
Remaining time/runs
Remaining time (dd:hh:mm) or number of runs for each assay with active QC lockout is shown. dd is the
number of days, hh is the number of hours, and mm is the number of minutes until the assay will be locked.
# is number of patient tests.
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