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Aesculap Spine
activ C handle, reamer guide, chisel guide, trial implants
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/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.
20
-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.
Store sterile packed single-use products dust-
protected in a dry, dark and temperature-
controlled room.
Technical Service
Risk of injury and/or mal-
function!
Do
WARNING
product.
For service and repairs, please contact your
national B. Braun/Aesculap agency.
Modifications carried out on medical technical
equipment may result in loss of warranty rights and
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.
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