3M ESPE Elipar DeepCure-L, Руководство по эксплуатации

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SEITE 10 - 148 x 210 mm - 3100021788/01 - SCHWARZ - 20-052 (kn)
Observe the manufacturer’s information about the
cleaning and disinfecting agents.
The light guide must not be exposed to temperatures
higher than 135 °C (275 °F).
The light guide has been tested for up to 500 steriliza-
tion cycles.
Limitations on Reprocessing
This medical device is safe to use if it is reprocessed
according to these instructions and no visible damage is
seen.
Inspect the device carefully before each use and dis-
card if there is any damage.
Point of use / Pre-Treatment
The contaminated light guide must be placed in an
approved, sealed container during transport from the
point of use to the reprocessing area.
The pre-treatment must be carried out before either
automatic or manual cleaning and disinfecting. Immedi-
ately after using (within a maximum of 2 hours), remove
gross contaminations from the light guide.
For this, rinse the light guide thoroughly under running
water (drinking water quality as a minimum) for at least
10 seconds.
Use a soft brush or a soft cloth to manually remove
any remaining contamination. Remove polymerized
composite with alcohol; a plastic spatula may help in
removing the material. Do not use any sharp or pointed
tools to protect the surface of the light guide from
scratching.
Cleaning and Thermal Disinfecting (Automated
Washer-Disinfectors / CDD (Cleaning and Disin-
fection Device))
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After the light guide has been pre-treated, place it in
the wire or sieve basket of the washer-disinfector.
Make sure that the devices do not touch one another
in the washer-disinfector.
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Remove the light guide from the washer-disinfector
unit at the end of the drying cycle and store it under
low germ count conditions.
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Examine the light guide for visible impurities. If any
impurities are visible, repeat the cycle in the washer-
disinfector.
Automated washer-disinfectors that meet the fol-
lowing requirements are suitable for use:
• The device generally has a certified effectiveness in
accordance with ISO 15883. The washer-disinfector
is regularly serviced and tested.
• If available, use a tested cycle for thermal disinfection
(A0 value > 600 or, for older devices, at least 5 min
at 90 °C/194 °F).
• The water used for rinsing is minimum drinking water
quality. Use low-germ and low-endotoxin water for
final rinsing.
• The air used for drying should be filtered (oil-free,
with low microbiological and particulate contamina-
tion).
Note: The evidence of suitability for automatic cleaning
and disinfection took place using the Miele G7336 CD
washer-disinfector (Gütersloh) and the cleaning agent
Thermosept RKN-zym (Schülke & Mayr). The program
D-V-THERMO0905, without drying time was used under
worst case conditions.
Cleaning
steps
Parameters
Pre-rinse
Temperature: 10 ° ± 2 °C
Time: 1 min
Cleaning
Cleaning temperature: 45 ° ± 2 °C
Time: 5 min
Cleaning solution:
Thermosept
RKN-zym
Concentration: 0.3% (3 ml/l)
Final rinse
Temperature: 10 ° ± 2 °C
Time: 2 min
Thermal
disinfection
Temperature 90 ° ± 2 °C
Time: 5 min
Cleaning and disinfection of the light guide by
wiping is only permitted in combination with a
corresponding protective sleeve
Manual Cleaning
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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 equivalent
cleaning agents.
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Follow the cleaning agent manufacturer’s directions
for use.
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Clean with the wipes until no contamination is visible.
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Then rinse with water (drinking water quality as a
minimum) and dry with a soft, lint-free cloth.
Manual Disinfection (Intermediate Level Disinfection)
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An intermediate level disinfection is possible only if
the light guide is covered with a protective sleeve
during use.