c) Mechanical / chemical cleaning
To be carried out immediately after pre-disinfection/chemical cleaning, wearing thick gloves. Scrub the
products in a new bath of enzymatic, quaternary ammonium base detergent / disinfectant solution, for
at least 30 seconds, and in any case until all remaining traces of contamination have been removed.
Rinse again under running water for at least 30 seconds.
d) Drying
Dry with a clean, non-woven single-use cloth, so as to remove any traces of liquid. Pack in single-use
sterilization pouches or bags in compliance with the specifications defined in standard EN ISO 11607-1 or
in any equivalent standard required by the national regulations.
e) Sterilization
The tips must be sterilized individually in an autoclave, according to the following parameters:
- autoclave: -type B, compliant with standard EN 13060;
- sterilization temperature: 134°C;
- sterilization stabilization time: 18 minutes;
- pressure: 2 Bars min.
f) Storage
Store the sterilized products in a dry place protected from dust. Before re-use, if the integrity of the
packaging is not certain, repackage then re-sterilize in accordance with the defined protocol.
If contamination is visible inside the bag, destroy the product.
g) Disposal of the product
Dispose of the product in receptacles for waste materials of healthcare activities involving infectious
risks.
CAUTION: Not all autoclaves can reach 134°C. Not all autoclaves draw a pre-vacuum. Please refer
to your autoclave manufacturer for specific sterilization instructions.
XII - -MONITORING / MAINTENANCE
Important:
In the case of a fault, you are advised to contact the supplier of your device. Do not use
unauthorized repairers, who might make your device dangerous for you and your patients.
12. 1 MONITORING
Regular monitoring of the device and its accessories is necessary in order to detect any insulation fault
or damage. Replace them if necessary.
It is important to keep the control unit ventilation vents clean in order to avoid abnormal heating.
12. 2 -PREVENTIVE AND CORRECTIVE MAINTENANCE
P
IEZOTOME
2 does not need any preventive maintenance other than monitoring of the accessories and
routine cleaning/disinfection.
Summary of Contents for Satelec Implant Center 2
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