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8. When you want to check the performance of the system.
B. Results for Test Strip, Level 1 Low Control and Level 2 High Control Solutions
should fall within the acceptable QC ranges. The meter cannot be used for
patient testing if it fails any quality control test. The meter will lock out and not
permit patient testing.
C. List of Corrective Actions for Failed QC:
Note: If QC fails either level 1 or level 2 or both levels, perform Corrective
Actions as follow:
1. Select Will Repeat Test in the pre-programmed comments on the meter.
2. Check expiration date of the control solutions and test strips.
3. Check the test strip lot number on the meter display and make sure it
matches the lot number on the test strip vial you are using.
4. Repeat QC using the same control solution and test strip vials.
5. If QC still fails, discard controls and open new control vials or use a
different lot number.
6. Select Will Use New Control Vial in the pre-programmed comments on
the meter.
7. If QC still fails, discard the test strips and open a new vial of test strips or
use a different lot number.
8. Select Will Use New Test Strip Vial in the pre-programmed comments on
the meter.
9. If QC still fails after changing the control solution and test strip vials,
remove the meter from service.
10. Select Notified BioMed in the pre-programmed comments on the meter.
11. Put a red tag on the meter, and return it to Clinical Engineering for further
evaluation, replacement, and downloading of data.
D. QC Lockout
1. At 12:01 AM every day the meter will prompt the user to run QC before
any testing is allowed. This message will appear.
QC Lockout
D-513. Warning! Quality
Control is due. Required
Controls must be run in order
to proceed. 2 STAT test(s)
available.”
2. The QC lockout feature may be overridden to allow the operator to run up
to (2) STATS if necessary prior to performing the QC tests.
3. Level 1 and level 2 quality control tests must be performed
IMMEDIATELY once a STAT test is run and results must be within
Acceptable Range in order for the patient’s result to be valid.
IX. QUALITY CONTROL TESTING PROCEDURE
Note: For efficiency, daily cleaning should be done and recorded when QC is performed by
selecting Cleaned Meter from the pre-program comments. (Refer to page 9 Maintenance
Policy and Procedure)
A. Press the power ON/OFF button to turn on the meter. The meter will perform
Self-Checks.
B. Touch the forward icon [] or wait 5 seconds to automatically proceed to the
Operator ID screen.
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