Cleaning/disinfection
Product-specific safety notes on the reprocessing procedure
►
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 a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical 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
For mechanical cleaning:
Note
Use appropriate (neutral, enzymatic and mild-alkaline) detergents on this product with its aluminum components.
Mechanical cleaning/disinfection with manual pre-cleaning
Note
The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark
according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
Manual pre-cleaning with ultrasound and brush
D–W:
Drinking water
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
►
Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible
surfaces are immersed and acoustic shadows are avoided.
►
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 min.
►
Mobilize non-rigid components, such as set screws, links, etc. during cleaning.
►
Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a
disposable syringe.
Phase II
►
Rinse/flush the product thoroughly (all accessible surfaces) under running water.
►
Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
Mechanical neutral or mild 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 neutral
►
Check visible surfaces for residues after mechanical cleaning/disinfecting.
►
Repeat the cleaning/disinfecting process if necessary.
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.
►
Assemble dismountable products, see Assembling.
►
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
Note
The product may only be sterilized when dismantled.
►
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
–
Disassemble the instrument
–
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.
Storage
►
Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
►
Use cleaning and disinfecting agents approved for, e.g., aluminum, plastics and
high-grade steel, according to the manufacturer’s instructions.
►
Observe specifications regarding concentration, temperature and exposure
time.
►
Do not exceed the maximum permitted cleaning temperature of 60 °C.
Validated procedure
Specific requirements
Reference
Manual pre-cleaning
with ultrasound and
brush and subsequent
mechanical neutral or
mild alkaline cleaning
and thermal disinfecting
■
Cleaning brush: 30 mm/
∅
: 4.5 mm,
e.g. TA no. 011944
■
20 ml disposable syringe
■
Mount jaws protection on the prod-
uct.
■
Place the instrument in a tray that is
suitable for cleaning (avoiding rinsing
blind spots).
■
Keep working ends open for cleaning.
■
Place instruments in the tray with
their hinges open.
Chapter Mechanical cleaning/disin-
fection with manual pre-cleaning and
sub-chapter:
■
Chapter Manual pre-cleaning with
ultrasound and brush
■
Chapter Mechanical neutral or
mild alkaline cleaning and thermal
disinfecting
Phase
Step
T
[°C/°F]
t
[min]
Conc.
[%]
Water
quality
Chemical
I
Ultrasonic
cleaning
RT (cold)
>15
2
D–W
Aldehyde-free, phenol-free,
and QUAT-free concen-
trate, pH ~ 9*
II
Rinsing
RT (cold)
1
-
D–W
-
Phase
Step
T
[°C/°F]
t
[min]
Water
quality
Chemical
I
Prerinse
<25/77
3
D–W
-
II
Cleaning
55/131
10
FD-W
Neutral:
■
Concentrate:
–
pH neutral
–
<5 % anionic surfactant
■
0.5 %* working solution
Mildly alkaline:
■
Concentrate:
–
pH = 9.5
–
<5 % anionic surfactant
■
0.5 % solution
III
Intermediate
rinse
>10/50
1
FD-W
-
IV
Thermal disin-
fecting
90/194
5
FD-W
-
V
Drying
-
-
-
According to the program for cleaning
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
