Technical Service; Distributor In The Us/Contact In Canada For Product Information And Complaints - Braun Aesculap Neurosurgery Instructions For Use/Technical Description

Sterilization for the US market
• Aesculap does not recommend the device sterilized
by flash or chemical sterilization.
• Sterilization may be accomplished by steam auto-
clave in a standard prevacuum cycle.
To achieve a sterility assurance level of 10
recommends the following parameters:
Aesculap Orga Tray/Sterilcontainer (perforated
bottom)
Minimum cycle parameters*
Sterilization Temp.
method
Pre-vacuum 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 Sterilcontainer cleared by FDA
for the sterilization and storage of these instruments.
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.
Storage
Store sterile products in germ-proof packaging
under dust protection in a dry, dark and
temperature-controlled room.
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, Aesculap
Time Minimum
drying time
4 min 20 min

Technical Service

Risk of injury and/or malfunction!
Do not modify the product.
WARNING
For service and repairs, please contact your
national B. Braun/Aesculap agency.
Modifications carried out on medical technical
equipment 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 Inc.
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.
Distributor in the US/Contact in Canada
for product information and complaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA 18034
USA
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