Eighteeth UltraMint Pro User Manual page 25

Reprocessing
validation study
information:
 Before sterilization, please remove the tip.
 Make sure that the handpiece is intact and not damaged before
sterilization or use, and do not apply any protective oil on the handpiece.
 The two O-rings on the handpiece cord (and the handpiece insertion point)
will be subject to force and wear during insertion and removal. Users can
apply dental lubricant to the O-ring in daily use. If the O-ring is damaged or
severely worn, causing water leakage or loose connection, please replace
the O-ring.
 The instructions provided above have been validated by the manufacturer
of the medical device as being capable of preparing a medical device for
use. It remains the responsibility of the processor to ensure that the
processing, as actually performed using equipment, materials and
personnel in the processing facility, achieves the desired result. This
requires verification and/or validation and routine monitoring of the
process. Likewise, any deviation by the processor from the instructions
provided should be properly evaluated for effectiveness and potential
adverse consequences.
6 Cleaning, Disinfection and Sterilization
and instructions for use.
 Sterility cannot be guaranteed if packaging is open,
damaged or wet.
 Check the packaging before using it (packaging
integrity, no humidity and validity period).
The above-mentioned reprocessing process (cleaning,
disinfection, sterilization)
validated. Refer to cleaning/disinfection validation test
reports No. RDS2020D0076 001 and RDS2020D0073
001; sterilization
RDS2020S0084 001 and RDS2020S0081 001.
has been
validation test
successfully
reports No.
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