B.Braun Aesculap Acculan 4 Mode D'emploi page 15

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Insert the product in its proper position in the ECCOS fixation. Insert
the battery compartment over the clamp and swivel device into the
ECCOS fixation so that the trigger 2 points upwards.
►
Ensure that the blade cover 13 is kept open through the entire pro-
cessing procedure.
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Dismantle the flap rod 23 for cleaning. Store flap rod 23, flaps 24 and
nut 26 separately in tray.
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After automatic cleaning/disinfection, check visible surfaces for resi-
dues and repeat the cleaning/disinfection process as needed.
7.10 Inspection, maintenance and checks
Note
Aesculap recommends lubricating the flap rod, flaps, sliding surfaces and
other moving parts, (e.g. trigger, cover lids) with STERILIT-Power-Systems
oil spray GB600 or the STERILIT-Power Systems drip lubricator GA059 prior
to every sterilization. Remove excess oil with a lint-free wipe.
►
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.
►
Check the product for any damage, abnormal running noise, overheat-
ing or excessive vibration.
►
Set aside the product if it is damaged.
7.11 Packaging
►
Always follow the instructions for use of the respective packaging and
storage devices (e.g. instructions for use TA009721 for Aesculap-
ECCOS holder system).
►
Insert the products in the correct position into the ECCOS fixations,
see Fig. G.
►
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.
7.12 Steam sterilization
Damage or destruction of the batteries due to pro-
cessing!
►
CAUTION Do not sterilize the rechargeable battery.
Note
The product may only be sterilized with the blade, battery and lid as well as
opened blade cover all demounted.
Note
The product can be sterilized with a mounted flap tab and flaps in the open
position.
►
Check to ensure that the sterilizing agent will come into contact with
all external and internal surfaces (e.g. by opening any valves and fau-
cets).
►
Use a validated sterilization method:
– Steam sterilization using fractional vacuum process
– Steam sterilizer DIN EN 285
DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding
time 5 min
When sterilizing multiple products in one steam sterilizer:
►
Ensure that the maximum permitted load specified by the manufac-
turer for the steam sterilizer is not exceeded.
7.13 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
following parameters:
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization Temp.
method
Prevacuum 270 °F/275 °F
*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 alterna-
tive method using appropriate laboratory techniques. Use an FDA cleared
accessory to maintain sterility after processing, such as a wrap, pouch, etc.
7.14 Storage
►
Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
►
Store sterile single-use GB228R product in germ-proof packaging in a
dry, dark and temperature-controlled room.
and validated pursuant
-6 , Aesculap recommends the
Time Minimum drying time
4 min 20 min
to
13