Cleaning And Disinfection; Reprocessing Of Reusable Ear Specula - Riester e-scope Mode D'emploi

4.8. Cleaning and disinfection

To avoid possible cross-contamination, the diagnostic instruments and their handles
must be cleaned and disinfected regularly.
The diagnostic instruments together with their handles can be cleaned on the outside
using a damp cloth (if necessary, moistened with alcohol) until they are visually clean.
Wipe with disinfectant (e.g. disinfectant Bacillol AF from Bode Chemie GmbH (time
30s)) only according to the instructions of use of the respective manufacturer of disin-
fectant. Only disinfectants with proven effectiveness according to national guidelines
should be used. After disinfecting, wipe the instruments with a damp cloth to remove
potential residue.
Please make sure that the cloth is moistened but NOT saturated, so that no moisture
penetrates the openings in the diagnostic instrument or its handle.
Make sure that glass and lenses are only cleaned with a dry and clean cloth.
Caution!
The diagnostic sets are not sterile devices; they cannot be sterilized
Caution!
Never place the instrument heads and handles in liquids! Make sure that no liquids
penetrate the housing interior! The device is not approved for machine reprocessing
and sterilisation. It can lead to irreparable damage!
If a reusable device shows signs of material deterioration, it should no longer be reu-
sed and should be disposed of/claimed according to the procedures described in the
Disposal/Warranty sections

4.8.1. Reprocessing of reusable ear specula

Required equipment: mildly alkaline cleaner (e.g. neodisher Mediclean, Dr. Weigert
404333 has been validated) 15°C-50°C, cleaning brush (Interlock 09098 and 09050
have been validated), tap water/running water 20±2°C of at least drinking water qua-
lity, tub/basin for cleaning agent, lint-free cloths (Braun Wipes Eco 19726 have been
validated).
1. The cleaning solution is produced according to the manufacturer's instructions for
the cleaning agent (neodisher Mediclean 0.5% has been validated).
2. Completely immerse the medical devices in the cleaning solution.
3. Make sure that all surfaces are completely wetted with cleaning solution.
4. Carry out all subsequent steps below the liquid level to prevent the contaminated
liquid from splashing.
5. Brush the hard-to-reach areas of the immersed ear specula with a soft brush
during the exposure time. Pay attention to the critical, hard-to-reach places where
a visual assessment of the cleaning effect is not possible.
6. The total exposure time in the cleaning solution is at least 10 minutes (10 minutes
has been validated).
7. Remove the medical devices from the cleaning solution.
8. Rinse the medical devices under running tap water (at least drinking water qua-
lity) for at least 1 minute (1 minute has been validated) to completely remove any
supernatant or residual cleaning solution. Check that the device is clean; if soiling
is visible, repeat the above steps.
9. Dry with a lint-free cloth.
Disinfection: manual
Required equipment: Disinfectant (e.g. CIDEX OPA, Johnson & Johnson 20391 has
been validated), demineralised water (demineralised water free of facultative patho-
genic microorganisms according to the KRINKO/BfArM recommendation) 20±2°C,
sterile, lint-free cloths.
1. Prepare the disinfectant solution according to the manufacturer's instructions (CI-
DEX OPA is a ready-to-use solution; the concentration must be checked using test
strips, see manufacturer's instructions) (CIDEX OPA has been validated).
2. Completely immerse the ear specula in the disinfectant solution.
3. Exposure time of the disinfectant solution according to the manufacturer's inst-
ructions for high-level disinfection (CIDEX OPA for 12 minutes has been validated).
4. Remove the ear specula from the disinfectant solution and place them in a tub/
basin containing demineralised water for at least 1 minute (1 minute has been
validated).
5. Repeat the step twice with fresh demineralised water.
6. Place the ear specula on a clean, dry cloth and allow to dry.
Further information for the user:
For information on cleaning and disinfection, refer to the current DIN EN ISO 17664
standard.
27