13
INSTRUCTIONS FOR CLEANING AND STERILIZATION OF MINILIGHT, MINIMATE,
MINIBRIGHT SYRINGES IN ACCORDANCE WITH UNI EN ISO 17665 REQUIREMENTS
Warning
• Sterilization must be performed even when using the syringe for the first time.
• Inappropriate sterilization is dangerous for patients and operators.
• Do not perform spray sterilization. Do not place in any disinfectant liquids.
• Do not perform cold chemical or hot air sterilization.
• The appointed staff must be specialized and trained.
• Use the disinfectant in accordance with the specifications set by the
manufacturer indicated on the label.
• Do not use chlorine-based solutions.
• When sterilizing more than one piece in one autoclave do not exceed its
maximum load capacity.
Preparation
Remove dirt from the surface using a disposable paper tissue.
Let air and water flow from the syringe for about 30 seconds in order to clean
the internal channels.
Press the button locateci at the bottom of the sleeve and slide the stainless
steel sleeve off the syringe body.
Unscrew the ferrule and remove the tip.
Manual cleansing
Wipe with a disposable paper tissue and with the aid of drinking water to
remove any impurities and dirt
Automatic cleansing
Not available
Manual disinfection
Perform disinfection only with a disposable tissue and with compatible
disinfectants (in accordance with the instructions included in the product label
and technical data sheet). Recommended disinfectants:
• lncidin liquid
• FD 322 Durr
• Mikrozid AF Liquid
Automatic disinfection
Not available
Manual drying
Dry with disposable paper tissue.
Dry with dry, clean and uncontaminated compressed air both internally and
externally until completely dry.
Do not dry with hot air.
Automatic drying
Not available
Maintenance and checking
No particular maintenance is required.
There is no objective term limiting the usage life of the sleeve: check to see if
there are if any damages or signs of wear and tear, replace the part if necessary.
Packaging
Use appropriately sized sterilization packages made of thermoweldable film.
Sterilization
The sleeve and tip are autoclavable.
Sterilize using EN 13060 ISO 17665-1 compliant class-B steam autoclave.
Sterilize with 3 phases fractionated vacuum 134° C +/- 1 °C with 2.13 bar
pressure, 4 minutes wait.
Never exceed 135° C.
The autoclave must be validated.
Preservation
No particular requirements other than keeping them in their sealed and
sterilized package. Keep them in an appropriate environment and out of direct
sunlight and in a dry place, which should have low bioburden where possible.
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