Manual Cleaning; Manual Disinfection - Mpv Medical Microdrop Rf6 Plus Gebrauchsanweisung

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2. Manual Cleaning

An alternative method to mechanical cleaning and disinfection
is the manual method:
a. Equipment
• Cleaning agent Korsolex® Endo Cleaner 0.5 % (Bode)
• Brush
• Warm water (approx. 50°C)
b. Procedure
• Disassemble completely the nebulizer and place each part
and the accessories in the cleaning solution.
• Clean the parts thoroughly with a brush.
• Carefully rinse the components with hygienically tested
water and let them dry completely on a clean, dry and
absorbent surface.
c. Validation
• Duration of cleaning procedure: approx. 5 minutes

3. Manual Disinfection

Select a suitable disinfectant solution that has been proven to
be effective and compatible with the materials of the accesso-
ries (PP , TPE, PVC, Silicone):
a. Equipment
• Disinfectant Korsolex® Basic 4% (Bode)
• Water
b. Procedure
• Disassemble completely the nebulizer and place each part
and the accessories in the disinfectant solution.
• Leave the accessories in the solution for the time indicated
in the instructions of the disinfectant
• Carefully rinse the components with hygienically tested
water and let them dry completely on a clean, dry and
absorbent surface.
c. Validation
• Treatment time: about 15 minutes
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4. Sterilization
a. Equipment
• Steam sterilizer – preferably with fractionated pre-vacuum
– in accordance with DIN EN 285 or DIN EN 13060 (type B)
b. Procedure
• Disassembly the nebulizer as shown in pictures and pack
the components together with the accessories in a sterile
barrier system in accordance with DIN EN 11607 (e.g. foil-
paper packaging)
• Maximum sterilization temperature and holding time:
121 °C, at least 20 min. or
134 °C, at least 3 min.
c. Validation
• The sterilisation procedure is validated in its conformity to
ISO 17665-1.
NOTE: A validated sterilization process can only be carried out
on products that have been cleaned and disinfected.
LIMITS
The nebuliser can be sterilised up to 300 times and used for
up to one year. Do not expose the nebuliser or accessories to
temperatures above 134° C. The connection tubing cannot be
processed for re-use.
Use original manufacturer accessories and spare
parts only. The manufacturer will not be liable if
non original accessories or spare parts are used.
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