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Coltene SciCan BRAVO G4 Manuel D'utilisation page 7

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1.6
RESIDUAL RISKS
FOR THE USER
Contamination due to improper handling of the load.
Burn by contact with hot surfaces or fluids.
FOR THE PATIENT
Contamination due to unsterilized material caused by incorrect cleaning treatment before sterilization.
Contamination due to implementation of incorrect reprocessing procedures.
Contamination due to material unsuitable for sterilization or not compliant with instructions for use.
Contamination due to unsterilized material caused by incorrect final assessment of sterilization process.
Contamination due to missing or incorrect scheduled maintenance.
Contamination due to missing periodic validation.
1.7
INFORMATION ON MITIGATION OF RESIDUAL RISKS
FOR THE USER
Contamination due to improper handling of the load.
See chapter PREPARING THE MATERIAL.
Burn by contact with hot surfaces or fluids.
To extract the sterile material, once the sterilization process has been completed with saturated steam at 121°C / 250°F or
132°C / 270°F, proceed as follows:
Always wear PPE suitable for the handling of hot material and gloves of appropriate material and thickness.
Clean your gloved hands with a germicide detergent.
Always use the special tray extractor, supplied as standard, to extract the trays from the sterilization chamber.
Avoid any contact of trays and material with contaminated and/or non-heat-resistant surfaces.
Handle the sterile material making sure not to damage any packages, bags and containers serving as a barrier.
FOR THE PATIENT
Contamination due to unsterilized material caused by incorrect cleaning treatment
before sterilization.
See chapter TREATING THE MATERIAL BEFORE STERILIZATION.
Contamination due to implementation of incorrect reprocessing procedures.
Make sure to use sterile material.
Contamination due to material unsuitable to sterilization or not compliant with
instructions for use.
Check that the contaminated material is compatible with the selected sterilization process.
Immediately separate the materials to be sterilized from those that must not be subjected to such process or are
not able to withstand it.
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