Coltene SciCan BRAVO G4 Manuel D'utilisation page 8

Contamination due to unsterilized material caused by incorrect final assessment of
sterilization process.
The sterilization process electronic control system monitors the various phases, at the same time checking that the
various parameters are respected; if any type of anomaly is encountered during the cycle, the program is immediately
interrupted, generating an alarm identified by a code, with a relative message explaining the nature of the problem.
Furthermore, the sterilization process can be checked by means of:
CHEMICAL INDICATORS
That monitor the sterilization process by providing information, together with the control of physical and biological
parameters, on the conditions occurred in the sterilization chamber during the process.
The final toning of the process indicator does not certify that the product is sterile but only that the device has been
subjected to a sterilization process. If the toning does not occur, the operator in charge of releasing the sterile material,
that must not be used, must put all actions to avoid the use of the treated material.
PHYSICAL INDICATORS
They include the reading of machine data and the execution of specific tests indicated during the validation phase for
that specific cycle/load/autoclave. This control system can include:
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Direct reading of the synoptic system (thermometer, pressure gauge, recorder, etc.).
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Reading of prints/labels/files on which the data detected by the synoptic system are stored (parameters).
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Execution of specific tests (Vacuum test, Bowie Dick test) according to local guidelines.
The operator in charge of the process certifies the validity of the load at the end of every cycle by means of the
parametric release.
Contamination due to missing or incorrect scheduled maintenance.
The sterilizer, based on a preset programming, displays a warning message relating to the scheduled maintenance
necessary to ensure the good operation of the device.
Contamination due to missing periodic validation.
See chapter PERIODIC STERILIZER VALIDATION.
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