Phase I
►
Fully immerse the product for at least 5 min in the cleaning solution.
Ensure that all accessible surfaces are moistened.
►
Clean the product immersed in the solution, using a soft cloth or, if
necessary, a soft cleaning brush, until all visible residues have been
removed from the surfaces.
►
If applicable brush through all surfaces that are not accessible to visual
inspection for at least 1 minute.
►
During cleaning, mobilize non-rigid components, such as set screws,
joints, slides, etc., 3 times in each direction to the positive stop.
►
After cleaning, use a suitable disposable syringe to thoroughly rinse
these parts of the product that are difficult to access at least 3 times.
Phase II
►
Rinse/flush the product (all accessible surfaces) thoroughly for at least
1 minute under running water.
►
During rinsing, mobilize non-rigid components, such as set screws,
joints, slides, etc., 3 times in each direction to the positive stop.
►
Perform these steps at least 3 times.
►
Drain any remaining water fully.
Phase III
►
Fully immerse the product for at least 12 minutes in the disinfectant
solution.
►
During rinsing, mobilize non-rigid components, such as set screws,
joints, slides, etc., 3 times in each direction to the positive stop.
►
Rinse lumens at least 3 times at the beginning of the exposure time,
using a disposable syringe. Ensure that all accessible surfaces are
moistened.
Phase IV
►
Following disinfection, rinse/flush the product completely (all accessi-
ble surfaces) for at least 2 minutes.
►
During rinsing, mobilize non-rigid components, such as set screws,
joints, slides, etc., 3 times in each direction to the positive stop.
►
Rinse lumens at least 3 times at the beginning of the exposure time,
using a disposable syringe.
►
Perform these steps at least 3 times.
►
Drain any remaining water fully.
Phase V
►
Dry the product with suitable tools.
6.7
Sterilization
Damage to the camera control unit by sterilization!
►
Do not sterilize the camera control unit under
any circumstances.
CAUTION
►
Clean the camera control unit by surface disin-
fection only.
Damage to the camera head and the adapter
caused by inappropriate sterilization processes!
►
Never sterilize the camera head and the adapter
CAUTION
with steam or in an autoclave.
►
Do not carry out chemical sterilization.
Working with disposable sterile covers
►
Use suitable Aesculap disposable sterile covers. Follow the instructions
for use of the sterile covers.
Approval of compatibility of materials exists for:
ETO-sterilization
6.8
Inspection, maintenance and checks
►
Allow the product to cool down to room temperature.
►
Inspect the product after each cleaning and disinfecting cycle to be
sure it is: clean, functional, and undamaged.
►
Set aside the product if it is damaged.
6.9
Packaging
►
Follow the instructions for use for the applied packaging and storage
systems (e.g. instructions for use TA009721 for Aesculap Eccos® stor-
age system).
►
Insert the product in its proper position in the Eccos® holder, or put it
on a tray in such a way that the product is protected against damage.
Ensure that all cutting edges are protected.
►
Pack trays appropriately for the sterilization process (e.g. in Aesculap
sterile containers).
►
Ensure that the packaging will prevent a recontamination of the prod-
uct.
6.10 Storage
►
Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
►
Store sterile packed single-use products dust-protected in a dry, dark
and temperature-controlled room.
17