Siemens ADVIA 2120, Operator'S Manual, Page: 390 / 477

Regulatory Information 9-49
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 the ADVIA 120 BASO, ADVIA 120 PEROX 1,
ADVIA 120 PEROX 2, ADVIA 120 PEROX 3, and ADVIA 120 PEROX
SHEATH reagents are stable for 90 days.
Calibrators and Controls
Protect product from freezing.
When stored at 2°C to 8°C, unopened ADVIA OPTIpoint (Prod. No. 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 ADVIA SETpoint Calibrator (Prod. No. T03-3685-01).
Please refer to page 5 for product descriptions.
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.