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Cleaning and sterilization procedure
Step 1: Clean the tip manually using soap water and a brush immediately
after use. A mild dishwashing detergent or similar is recommended.
Inspect the mirror of the tip after cleaning. If the mirror appears with
stains, smudged or with a milky haze, repeat cleaning using a soft dish-
brush and soap water. Rinse with water.
Dry the mirror carefully with a paper towel.
Step 2: Put the tip in a steam pouch suitable for sterilization.
The pouch should be sealed. Use either a self-adhesive pouch or heat-
sealed pouch.
Step 3: Sterilize the pouched tip in an autoclave with one of the two
programs:
• At 134 °C (273.2 °F) for a minimum of 3 minutes.
• At 121 °C (249.8 °F) for a minimum of 15 minutes.
Use an autoclave program that dries the pouched tip before opening
the autoclave.
Cleaning and high-level disinfection procedure
Step 1: Clean the tip manually using soap water and a brush immediately
after use. A mild dishwashing detergent or similar is recommended.
Inspect the mirror of the tip after cleaning. If the mirror appears with
stains, smudged or with a milky haze, repeat cleaning using a soft dish-
brush and soap water. Rinse with water. Dry the mirror carefully with
a paper towel.
Step 2: Disinfect the tip using Wavicide-01 Solution
Immerse the tip completely in Wavicide-01 for 45 to 60 minutes.
See also the Wavicide-01 Solution Instructions for Use.
Step 3: Rinse the tip
After having been immersed in the Wavicide-01 Solution for 45
to 60 minutes, the tip should be removed and rinsed according
to the Wavicide-01 Solution Instructions for Use.
Step 4: Dry the tip
Use a sterile and non-abrasive paper towel or cloth to gently remove
remaining drops from the mirror and to dry the tip.
CAUTION
The mirror in the tip is a delicate optical component. Its
clean and undamaged surface is critical for the scan quality.
The mirror should be handled with care. Do not scratch it.
Be careful not to smudge it before scanning a patient.
CAUTION
Always clean the tip immediately after use. If biological
materials (bioburden) are allowed to dry on equipment,
disinfection and sterilization processes may not be effective.
CAUTION
Never autoclave a tip that is not pouched, since this
will leave stains on the mirror that cannot be removed.
See the autoclave manual for more information.
CAUTION
New tips must be cleaned and sterilized / autoclaved
before using them for the first time.
CAUTION
A class B Vacuum autoclave according to EN13060
is required for sterilization of the scanner tip.
CAUTION
The scanner tip with fixed mirror can be re-sterilized up to
150 times and must be disposed afterwards as described in
section 7. Disposal.
CAUTION
The scanner tip can be high-level disinfected up to 150
times with Wavicide-01 Solution and must be disposed
afterwards as described in section 7. Disposal.
CAUTION
When high-level disinfecting the scanner tip using
Wavicide-01 Solution there may be a visual change to the
tip after 70 disinfections. This change is only visual and
does not pose a risk.
IMPORTANT NOTICE
High-level disinfection with Wavicide-01 Solution as an
alternative to sterilization has been validated by 3Shape.
The Wavicide-01 Solution is not allowed and/or recognized
as a disinfectant of medical devices worldwide, always
follow procedures that have been established for your
clinic or institute, as well as any national guidelines.
IMPORTANT NOTICE
Always follow cleaning, disinfection and sterilization
procedures that have been established for your clinic or
institute, as well as national guidelines.
IMPORTANT NOTICE
If using Wavicide-01 for high-level disinfection, be sure
to follow the Wavicide-01 Solution Instructions for Use.
6.2 Cleaning, disinfecting and sterilizing
the Color Calibration Kit
The color calibration adaptor must always be attached on a cleaned and
sterilized scanner tip and must not have contact with patients. If these
instructions are not followed the color calibration kit must be cleaned,
disinfected and sterilized.
Cleaning, disinfection and sterilization procedure
Step 1: Disassemble the color calibration kit (remove the sleeve from
the color calibration target and disassemble the color calibration target
and the color calibration adaptor).
Step 2: Clean the color calibration adaptor manually using soap water
and a brush. Sterilize the cleaned color calibration adaptor in an
autoclave using one of the programs listed for the scanner tip and using
a steam pouch suitable for sterilization.
Step 3: Clean the sleeve manually using soap water and a brush.
Disinfect the sleeve using the recommended disinfection solution listed
in section 6.3 Cleaning and disinfecting other parts of the system.
Step 4: The color calibration target must only be cleaned with air.
The calibration patches must not be touched and must not be exposed
to liquids. See the important notice below.
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