Product Manual

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Admin User can define the QC Testing time
intervals. The time intervals options are; Daily,
Weekly, Monthly and No cycle.
Note: For waived testing performed under a
CLIA Certificate of Waiver, quality control
checks must be performed by following manufacturer’s
instructions. Coag-Sense User Instructions recommends testing
one set of Controls (High and Low) per new Lot# of Patient Test Strip
Kits immediately upon receipt of shipment. All boxes with the same
lot # from that shipment are then qualified and “QC Done” can be
written on the top of all the boxes. Some States and Accrediting
Agencies may have additional requirements or regulations for
waived QC testing frequency. The meter does not require the
running of controls for any calibration.
If the Control tests (High Control or Low control) do not produce a result,
or if the result is outside of the target value range, the meter is locked from
further patient testing until a valid QC result is obtained. The Test button
will be grayed with a lock symbol indicating that it is in QC lockout mode.
The Admin User when logged in, can override the QC Lockout function
either by disabling the QC lock feature or by changing the QC testing time
interval. This will allow patient testing to proceed and the Test button will
turn blue again. Standard Users cannot change the QC Lock Setting, only
the Admin user can change the settings.