Sterilization For The Us Market; Technical Service - B. Braun Aesculap Gebrauchsanweisung/Technische Beschreibung

Aesculap ®
activO frame system

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
recommends the following parameters:
Aesculap Orga Tray/Sterile container (perforated
bottom)
Minimum cycle parameters*
Steriliza- Temp.
tion method
Prevacuum 270 °F/
275 °F
*Aesculap has validated the above sterilization cycle
and has the data on file. The validation was accom-
plished in an Aesculap sterile container cleared by FDA
for the sterilization and storage of these products.
Other sterilization cycles may also be suitable, how-
ever individuals or hospitals not using the recom-
mended 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 sus-
pected of having Creutzfeldt-Jakob Disease (CJD),
the device cannot be reused and must be destroyed
due to the inability to reprocess or sterilize to elim-
inate the risk of crosscontamination.
26
-6 , Aesculap
Time Minimum
drying
time
4 min 20 min
Storage
►
Store sterile products in germ-proof packaging,
protected from dust, in a dry, dark, temperature-
controlled area.

Technical Service

Risk of injury and/or malfunc-
tion!
►
WARNING
►
For service and repairs, please contact your
national B. Braun/Aesculap agency.
Modifications carried out on medical technical equip-
ment may result in loss of guarantee/warranty rights
and forfeiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: +49 (7461) 95-1602
Fax: +49 (7461) 16-5621
E-Mail: ats@aesculap.de
Or in the US:
Aesculap Implant Systems LLC
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042
Aesculap Repair Hotline
Phone: +1 (800) 214-3392
Fax: +1 (314) 895-4420
Other service addresses can be obtained from the
address indicated above.
Do not modify the product.