Technical Service; Distributor In The Us/Contact In Canada For Product Information And Complaints - B. Braun Aesculap PROSPACE SN002R Gebrauchsanweisung/Technische Beschreibung

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 -6 , Aesculap recommends the following parameters:
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization method Temp.
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 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 suspected of having Creutzfeldt-Jakob Disease (CJD), the device
cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate 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.
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and for-
feiture 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
TA-Nr. 013462 2018-07 V6 Änd.-Nr. 58438
Time Minimum drying time
4 min 20 min