Siemens ADVIA 2120, Operator'S Manual, Page: 357 / 477

9-16 Regulatory Information
Product
Number Contents Amount (mL)
04408568 T03-3682-54 OPTIpoint 4 x 6.0 mL
- T03-3682-01 OPTIpoint 6.0 mL
•
ADVIA 120 SETpoint Calibrator
Product
Number Symbol Contents Amount
(mL)
09170071 T03-3685-52 Hematology
Calibrator 2 x 6.1 mL
- T03-3685-01 Hematology
Calibrator 6.1 mL
System Method Information: Calibration
This topic specifies the calibration type, frequency, and procedure for each
method and identifies the calibration material to be used, where appropriate.
Calibration Procedure
The system must be calibrated for all parameters except % Retics. Siemens
recommends the use of ADVIA SETpoint Calibrator (Prod.No. T03-3685-01).
Calibration should be performed in each of the following cases:
•
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.
System Method Information: Results
This topic describes expected flags or messages associated with analytical
results.
System Method Information: Limitations of the Procedure
This topic describes substances, conditions, and patient states that have been
reported to cause actual or apparent changes in the analytical results.
Siemens makes every effort to identify in the Troubleshooting, Maintenance, and
Bibliography topics of the Product Labeling, the potential effects caused by
instruments, reagents, or endogenous substances, including known interferences
on patient results. However, it is impossible to provide information that would be
applicable to every clinical situation. This information is provided in lieu of
attempting to define the need for additional testing which involves medical
judgement in individual cases. The decision whether or not to report a diagnostic
result rests with the laboratory.