3Shape TRIOS S1P-2 Manuale di configurazione - Pagina 10

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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 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 paper sterilization pouch
The pouch should be sealed airtight. 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. A class B Vacuum autoclave according to EN13060 is
required for sterilization of the scanner tip.
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 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: Immerse the tip completely in Wavicide-01 for 45 to 60 minutes.
Step 3: Remove the tip from the Wavicide-01 solution and rinse it
according to the Wavicide-01 Solution instructions for use.
Step 4: 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 an unpouched tip, since this will leave
unremovable stains on the mirror. See the autoclave
manual for more information.
CAUTION
New tips must be cleaned and sterilized/high-level
disinfected before using them for the first time.
10
CAUTION
A class B Vacuum autoclave according to EN 13060
is required for sterilization of the scanner tip.
CAUTION
The scanner tip can be re-sterilized up to 150 times and must
be disposed afterwards as described in section 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 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, high-level disinfecting,
and sterilizing the calibration kit
The color calibration adaptor must always be attached on a cleaned and
sterilized scanner tip and must not have contact to patients. If these
instructions are not followed the color calibration kit must be cleaned,
disinfected and sterilized.
Cleaning, high-level 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 paper sterilization pouch.
Step 3: Clean the sleeve manually using soap water and a brush.
Disinfect the sleeve using the recommended disinfection solution
listed in section 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.