Bd Focalpoint™ Slide Profiler System Integrity - BD FocalPoint GS User Manual

23 BD FocalPoint™ Slide Profiler System Integrity
BD has built into its BD FocalPoint™ GS Imaging System a comprehensive, fully automated
quality assurance technology called System Integrity (SI). SI validates slide results produced by
the BD FocalPoint™ GS Imaging System by regular monitoring of the system operating
parameters.
The objectives of the System Integrity tests are to:
• Assure that system performance is consistent and within design limits.
• Provide trend analysis data for maintenance.
• Facilitate effective repairs, when necessary.
The BD FocalPoint™ GS Imaging System has five basic functional subsystems: illumination,
image collection, autofocus, positioning, and processing. SI automatically measures nearly
1,000 parameters, fully characterizing these subsystems. This characterization takes place
frequently and is compared to design limits to validate slide results. When the device is operating
within limits, slide results are validated and reported to the laboratory.
SI characterization provides information for periodic service events. While SI results are checked
frequently, they are also permanently logged, providing a diagnostic record of the device that can
be accessed remotely. Thus, service can be anticipated, rapid, and effective.
SI tests are performed automatically after each tray of slides is processed. If any subsystem fails
a system integrity check, the slide results for the previous tray are invalidated. The system then
attempts to recalibrate itself, and then, if successful, goes on to the next tray. SI also monitors
and tracks expected drift in the operating parameters and may initiate automatic recalibration to
ensure that calibration is performed before calibration limits are exceeded. When this
recalibration occurs, slide results for the previous tray are not invalidated.
There are four possible outcomes from System Integrity (SI):
• Pass — SI tests passed; slide processing can continue.
• Pass-recalibrate — SI tests passed; a calibration was run to avoid future test failures.
Reject previous tray — A test failed that requires the previous tray's results to be rejected.
•
However, calibration successfully brought the system back within specifications.
• Error — An error occurred that requires the previous tray's results to be invalidated. The
BD FocalPoint™ instrument stops processing slides. Sometimes, the error will be corrected
through an automatic reboot of the instrument.
Although system integrity usually takes approximately five minutes,
it can take as long as 30 minutes. Sometimes the system must
repeat certain tests to validate results, which causes the longer SI
NOTE
run times.
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