3M Elipar DeepCure-L Mode D'emploi page 13

SEITE 11 - 148 x 210 mm - 3100021788/01 - SCHWARZ - 20-052 (kn)
Disinfect the light guide with ready-to-use disinfec-
tant wipes (e.g., CaviWipes™ based on the active
substances alcohols and quaternary compounds
(QAV)) or equivalent disinfection agents. Follow the
disinfection agent manufacturer's directions for use,
observing in particular the contact times.
Then rinse with water (drinking water quality as a
minimum) and dry with a soft, lint-free cloth.
Manual Cleaning and Disinfection the Light Guide
by Immersion Bath
Manual Cleaning
A neutral enzymatic cleaning agent is recommended
(e.g., Cidezyme/Enzol from Johnson & Johnson).
Place the light guide for the specified application time
into the solution, making sure that it is completely
covered.
Cleaning takes place in the immersion bath with a
soft brush for at least 5 minutes.
Then remove the light guide from the solution, thor-
oughly rinse with low-germ-count water (drinking
water quality as a minimum), and dry with a lint-free
cloth.
Manual Disinfection (High Level Disinfection)
A disinfecting agent containing o-Phthalaldehyde
(e.g., Cidex OPA by Johnson & Johnson) is recom-
mended. It is compatible with the light-curing device.
To disinfect, place the cleaned light guide for the
specified application time (≥ 12 min) into the solu-
tion, making sure that it is completely covered.
The instruments in the disinfection bath must not
touch each other during this process.
Then remove the light guide from the solution, thor-
oughly rinse with low-germ-count water (drinking
water quality as a minimum) for at least 3 minutes,
and dry with a lint-free cloth.
Then check the light guide (see "Check").
1
Cleaning agent Thermosept RKN-zym (Schülke &
Mayr) for the washer-disinfector and Cidezyme
®
Enzol and CaviWipes™ were used for manual clean-
ing.
2
Cidex OPA, ready-for-use solution, was used for vali-
dation of the high level disinfection and CaviWipes™
for validation of intermediate level disinfection.
Packaging for Sterilization
Package the light guide in single wrapped sterilization
pouches (one-way packaging or double packaging).
Sterilization
Effective cleaning and disinfection are absolutely essen-
tial requirements for effective sterilization.
A fractionated vacuum procedure (at least 3 vacuum
stages) or a gravity procedure (with adequate product
drying) must be used for the sterilization. The use of the
less effective gravity procedure is permissible solely if
the fractionated vacuum procedure is unavailable. The
user is solely responsible for selection of the parame-
ters required for the gravity procedure; the user must
therefore calculate or validate these parameters in ac-
cordance with the loading configuration. The drying time
actually required is also directly dependent on parame-
ters that are in the sole responsibility of the user (load-
ing configuration and density, sterilizer condition, etc.)
and must consequently be determined by the user.
• Steam sterilizer in conformity with DIN EN 13060/DIN
EN 285 or ANSI AAMI ST79 (for USA: FDA clearance)
• Maximum sterilization temperature 135 °C (275 °F)
• The following cycles were validated for the light
guide:
Fractional prevacuum
132 °C
Temperature
(270 °F)
Sterilization
4 min
time
Drying time 30 min
Check
Before using the light guide again, check it for damaged
surfaces, discoloration, and contamination; do not use
damaged light guides. If the light guide is still contami-
nated, repeat all reprocessing steps.
Clean and Disinfect Handpiece and Glare Shield
• Cleaning and disinfecting solutions must not enter the
unit.
• Wipe the surfaces with ready-to-use disinfectant
wipes3 (e.g., CaviWipes™ based on the active sub-
®
/
stances alcohols and quaternary compounds (QAV) or
equivalent disinfection agents). Subsequently inspect
the surfaces for visible impurities. If any impurities
are visible, repeat the cleaning procedure.
• Solvents or abrasive cleaners may not be used as
they can damage the components.
• Wipe the device surfaces with a tuberculocidal disin-
fectant wipe3 for disinfection and keep it wet accord-
ing to the disinfection agent manufacturer's direc-
tions for use, particularly observing the contact time.
• Disinfectants must not be sprayed directly onto the
device surface.
• Wipe the device surfaces with a soft cloth moistened
with water (drinking water quality as a minimum) and
Gravity dis-
placement
134 °C 121 °C
(273 °F) (250 °F)
3 min 20 min
30 min 30 min
11