3M Elipar DeepCure-L Manual page 13

SEITE 11 - 148 x 210 mm - 44000118149/02 - SCHWARZ - 20-113 (kn)
Cleaning
steps
Cleaning temperature: 45 ° ± 2 °C
Time:
Cleaning
Cleaning solution:
Concentration:
Temperature:
Final rinse
Time:
Temperature
Thermal
disinfection
Time:
Cleaning and disinfection of the light guide by wip-
ing is only permitted in combination with a corre-
sponding protective sleeve
Manual Cleaning
E
Clean the light guide after every application for 30
seconds with ready-to-use disinfectant wipes (e.g.,
CaviWipes™ based on the active substances alco-
hols and quaternary compounds (QAV)) or equiva-
lent cleaning agents.
E
Follow the cleaning agent manufacturer's directions
for use.
E
Clean with the wipes until no contamination is visible.
E
Then rinse with water (drinking water quality as a
minimum) and dry with a soft, lint-free cloth.
Manual Disinfection (Intermediate Level Disinfection)
E
An intermediate level disinfection is possible only if
the light guide is covered with a protective sleeve
during use.
E
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.
E
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
E
A neutral enzymatic cleaning agent is recommend-
ed (e.g., Cidezyme/Enzol from Johnson & John-
son).
E
Place the light guide for the specified application
time into the solution, making sure that it is com-
pletely covered.
Parameters
5 min
Thermosept
RKN-zym
0.3% (3 ml/l)
10 ° ± 2 °C
2 min
90 ° ± 2 °C
5 min
E
Cleaning takes place in the immersion bath with a
soft brush for at least 5 minutes.
E
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)
E
A disinfecting agent containing o-Phthalaldehyde
(e.g., Cidex OPA by Johnson & Johnson) is recom-
mended. It is compatible with the light-curing de-
vice.
E
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.
E
The instruments in the disinfection bath must not
touch each other during this process.
E
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.
E
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
cleaning.
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 es-
sential 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 sole-
ly if the fractionated vacuum procedure is unavailable.
The user is solely responsible for selection of the pa-
rameters required for the gravity procedure; the user
must therefore calculate or validate these parameters
in accordance with the loading configuration. The dry-
ing time actually required is also directly dependent on
parameters that are in the sole responsibility of the us-
er (loading configuration and density, sterilizer condi-
tion, 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)
®
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