Coltene SciCan BRAVO G4 Manuel D'utilisation page 75

14.4 PERIODIC STERILIZER VALIDATION
As happens with all devices, it is possible, and sometimes inevitable, to have a decrease in performance and the
effectiveness of components along their lifespan, in a period of time dependent on its frequency of use.
To guarantee the safety of the process over time, it is periodically (depending on local guidelines or regulations)
necessary to verify, the thermodynamic process parameters (pressure and temperature), to check if they continue to
remain within allowed limits or not.
The requalification of the sterilizer's performance is the responsibility of the user of the product.
The reference standards ISO 17665-1 (Sterilization of health care products — Moist heat — Part 1: Requirements for
the development, validation and routine control of a sterilization process for medical devices) is an effective guide for
performing verifications on steam sterilizers.
Since, in addition to specific experience and training, these controls require the use of special equipment (high-precision
sensors and probes, data loggers, dedicated software, etc.) suitably verified and calibrated, it is necessary to contact a
company specialized in these activities.
Customer Service department (see Appendix) is available to provide any information relative to the periodic validation of steam sterilizers.
14.5 DEVICE USEFUL LIFE
Steam sterilizer service life is of 10 years (average use: 5 cycles/day, for 220 days/year). For normal use, it is expected that
the device is used and maintained according to the instructions provided by the manufacturer.
The expected useful life of the device was determined according to a risk analysis carried out in compliance with
requirements of standard ISO 14971.
14.6 DISPOSING THE EQUIPMENT WHEN NO LONGER USED
Concerning waste disposal, the unit must not be disposed of as municipal waste, but must be separated in accordance
with local provincial/state regulations.
Appropriate differentiated waste collection for subsequent recycling treatment and environmentally friendly disposal
contributes to preventing possible negative effects on the environment and health, and encourages recycling of
the materials of which the device is made up. The symbol indicating separate collection for electrical and electronic
equipment consists of the crossed out bin marked on the device.
Under national legislation, fines can be imposed if the product is disposed in an illegal manner.
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