Steam Sterilization; Sterilization For The Us Market; Storage; Maintenance - B. Braun Aesculap Acculan 4 Gebrauchsanweisung/Technische Beschreibung

7.10 Steam sterilization

Damage or destruction of the batteries due to pro-
cessing!
►
Do not sterilize the rechargeable battery.
CAUTION
Note
Remove all attached components from the product (tools, accessories)
before 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 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.

7.11 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.

7.12 Storage

►
Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
and validated pursuant
-6 , Aesculap recommends the
Time Minimum drying time
4 min 20 min
8.

Maintenance

To ensure reliable operation, the product must be maintained in accor-
dance with the maintenance labeling or at least once a year.
YYYY-MM
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
to
13