►
Do not use oxidizing chemicals (e.g. H
2
O
2
), which could cause bleaching/layer loss of the product.
►
Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-
tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the
product thoroughly with running water.
►
Carry out ultrasound cleaning:
– As an effective mechanical supplement to manual cleaning/disinfection
– as an integrated mechanical support measure for mechanical cleaning/disinfection.
– for additional cleaning of products with residues left after mechanical cleaning/disinfection.
►
Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the
positioning aids.
Validated cleaning and disinfection procedure
Manual cleaning/disinfection
►
Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-
infecting solution.
►
After manual cleaning/disinfection, check visible surfaces visually for residues.
►
Repeat the cleaning /disinfection process if necessary.
Manual cleaning with immersion disinfection
D–W:
Drinking water
FD–W:
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
RT:
Room temperature
*Recommended: BBraun Stabimed
►
Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infection procedure.
Phase I
►
Fully immerse the product in the cleaning/disinfecting solution for at least 15 minutes. Ensure that all accessible
surfaces are moistened.
►
Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed
from the surface.
►
If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 minute.
►
Mobilize non-rigid components, such as set screws and hinges, during cleaning.
►
Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a
suitable disposable syringe.
Phase II
►
Rinse/flush the instrument thoroughly (all accessible surfaces) under running water.
►
Mobilize non-rigid components, such as set screws and hinges, during rinsing.
►
Drain any remaining water fully.
Phase III
►
Fully immerse the instrument in the disinfectant solution.
►
Mobilize non-rigid components, such as set screws and hinges, during disinfection.
►
Rinse lumens at least five times at the beginning of the exposure time with an appropriate disposable syringe.
Ensure that all accessible surfaces are moistened.
Phase IV
►
Rinse/flush the instrument thoroughly (all accessible surfaces).
►
Mobilize non-rigid components, such as set screws and hinges, during final rinsing.
►
Rinse lumens at least five times using an appropriate disposable syringe.
►
Drain any remaining water fully.
Phase V
►
In the drying phase, dry the product via appropriate means (e.g., wipes, compressed air), see Validated cleaning
and disinfection procedure.
Mechanical cleaning/disinfecting
Note
It is essential that the cleaning and disinfection device used is officially recognized or certified as effective (with FDA
approval or a CE marking, for instance).
Note
The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
D–W:
Drinking water
FD–W:
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
*Recommended: BBraun Helimatic Cleaner alkaline
Inspection, maintenance and checks
►
Allow the product to cool down to room temperature.
►
After each complete cleaning, disinfecting and drying cycle, check that the instrument is dry, clean, operational,
and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured compo-
nents).
►
Dry the product if it is wet or damp.
►
Repeat cleaning and disinfection of products that still show impurities or contamination.
►
Check that the product functions correctly.
►
Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Tech-
nical Service.
►
Check for compatibility with associated products.
Packaging
►
Appropriately protect products with fine working tips.
►
Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected.
►
Pack trays appropriately for the intended sterilization process (e.g. in sterile Aesculap containers).
►
Ensure that the packaging provides sufficient protection against recontamination of the product during storage.
Steam sterilization
►
Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by
opening any valves and faucets).
►
Validated sterilization process
–
Steam sterilization through fractionated vacuum process
–
Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665
–
Sterilization using fractionated vacuum process at 134 °C/holding time 5 min
►
When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capac-
ity of the steam sterilizer specified by the manufacturer is not exceeded.
Sterilization for the US market
■
Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization.
■
Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave.
To achieve a sterility assurance level of 10
-6
, Aesculap recommends the following parameters:
*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an
Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles
may also be suitable, however individuals or hospitals not using the recommended method are advised to validate
any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility
after processing, such as a wrap, pouch, etc.
WARNING for the US market
If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device
cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of
crosscontamination.
CAUTION
Risk of damage to, or destruction of the temporary spikes due to reuse!
The temporary spikes are intended for single use only.
►
Do not reuse the temporary spikes.
Validated procedure
Specific requirements
Reference
Manual cleaning with immersion
disinfection
■
Do not reprocess the product
after use in the body.
■
Drying phase: Use a lint-free
cloth or medical compressed air
Chapter Manual cleaning/disinfec-
tion and sub-chapter:
■
Chapter Manual cleaning with
immersion disinfection
Mechanical alkaline cleaning and
thermal disinfection
■
Do not reprocess the product
after use in the body.
■
Place the instrument in a tray
that is suitable for cleaning
(avoiding rinsing blind spots).
Chapter Mechanical cleaning/dis-
infecting and sub-chapter:
■
Chapter Mechanical alkaline
cleaning and thermal disinfect-
ing
Phase
step
T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemicals
I
Disinfectant
cleaning
RT
(cold)
>15
2
D–W
Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
II
Intermediate rinse
RT
(cold)
1
-
D–W
-
III
Disinfection
RT
(cold)
15
2
D–W
Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
IV
Final rinse
RT
(cold)
1
-
FD-W
-
V
Drying
RT
-
-
-
-
Phase
step
T
[°C/°F]
t
[min]
Water
quality
Chemical/Note
I
Pre-rinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
■
Concentrate, alkaline:
–
pH = 13
–
<5 % anionic surfactant
■
0.5 % working solution
–
pH = 11*
III
Intermediate rinse
>10/50
1
FD-W
-
IV
Thermal disinfection
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for the clean-
ing and disinfection device
CAUTION
Damage (metal seizure/friction corrosion) to the product caused by insufficient
lubrication!
►
Prior to function checks, lubricate moving parts (e.g. joints, pusher compo-
nents and threaded rods) with maintenance oil suitable for the respective ster-
ilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray
JG600 or STERILIT® I drip lubricator JG598).
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization method
Temp.
Time
Minimum drying time
Prevacuum
270 °F/275 °F
4 min
20 min
