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

Aesculap Orga Tray/sterile container (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 sterile container 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,
protected from dust, in a dry, dark, temperature-
controlled area.

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.
Time Minimum
drying time
4 min 20 min
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 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.
Disposal
Adhere to national regulations when disposing of
or recycling the product, its components and its
packaging!
Distributor in the US/Contact in Canada
for product information and complaints
Aesculap Implant Systems, LLC.
3773 Corporate Parkway
Center Valley, PA 18034
USA
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