Siemens ADVIA 2120, Руководство оператора, Страница: 367 / 477

9-26 Regulatory Information
For
in vitro
diagnostic use.
Storage and Stability
Reagents
When stored between 15°C and 30°C:
•
All unopened reagents are stable until the expiration date printed on the
product label.
•
Opened containers of ADVIA 120 BASO reagent, ADVIA 120 HGB
reagent, and DEFOAMER are stable for 90 days.
•
Opened containers of ADVIA 120 SHEATH/RINSE and ADVIA 120
RBC/PLT reagent are stable for 45 days.
Protect product from freezing.
When stored at 2°C to 8°C, unopened ADVIA OPTIpoint (PN T03-3682-01),
ADVIA SETpoint Calibrator (PN T03-3685-01), and ADVIA TESTpoint
Hematology Controls (PN T03-3686-01, Low; T03-3687-01, Normal; and T03-
3688-01, High, respectively) are stable until the last day of the month of the
expiration date printed on the product label unless stated otherwise.
After being opened, ADVIA OPTIpoint is stable for 7 days, ADVIA TESTpoint
Hematology Controls are stable for 10 days, and the ADVIA SETpoint Calibrator
is stable for 5 days, when stored closed in their original containers at 2°C to 8°C.
Gain Adjustment
The gain adjustment procedure is used to adjust the amplification signals in a
channel to properly position the cell signatures within a cytogram.
Calibration
The system must be calibrated for all parameters except %RETIC. Siemens
recommends the use of the ADVIA SETpoint Calibrator (PN T03-3685-01).
Calibration procedure should be performed:
•
Upon installation of the system.
•
If there is a significant shift in control values after the replacement of a
critical hardware component or reagent lot, after checking gains.
•
Anytime control results and/or moving averages are out of range and it has
been verified that the out-of-control condition is instrument-related.