38
2. In addition, prepare a fresh immersion bath with purified wa-
ter (aqua purificata).
3. Immerse the product completely in a cleaning bath, ensuring
that the product does not come into contact with other com-
ponents in the bath.
4. Thoroughly clean the surfaces with a soft brush/soft dispos-
able cloth.
5. Rinse the surfaces with tap water (at least 1 minute).
6. Repeat the preceding cleaning steps if the product still
shows visible contamination.
7. Dry the product until there are no more fluid residues visible
(e.g. with filtered compressed air).
8. Immerse the product completely in a disinfectant bath, en-
suring that the product does not come into contact with oth-
er components in the bath.
9. Wipe all bubbles off the product surface with a soft dispos-
able cloth. Move/turn the product a number of times so that
the disinfectant solution reaches all parts of the product.
10. To rinse, fully immerse the product in the prepared immer-
sion bath. Leave it in the water for at least one minute, mov-
ing it back and forth several times.
Repeat this procedure twice more, using a freshly prepared
and uncontaminated immersion bath each time.
11. Dry the product until no residual liquid is visible, using a ster-
ile lint-free disposable cloth.
5.7 Cleaning and Disinfection by Machine
The washer/disinfector must be in accordance with applicable
national standards and regulations (e.g. ANSI/AAMI ST15883).
The detergent and disinfectant must be suitable for medical de-
vices made of plastic and metal and have a pH value between 5.5
and 12.3.
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