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7.11 Steam sterilization
Note
For further information, see Technical Data.
►
Make certain that all external and internal surfaces of the product will
be exposed to the sterilizing agent.
►
Validated sterilization process
– Steam sterilization using fractional vacuum process
– Steam sterilizer according to DIN EN 285 and validated according
to DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding
time 5 min
►
When sterilizing several instruments at the same time in a steam ster-
ilizer: ensure that the maximum load capacity of the steam sterilizer
specified by the manufacturer is not exceeded.
7.12 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
following parameters:
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization
Temp.
method
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 alterna-
tive method using appropriate laboratory techniques. Use an FDA cleared
accessory to maintain sterility after processing, such as a wrap, pouch, etc.
7.13 Storage
►
Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
-6
, Aesculap recommends the
Time
Minimum drying time
4 min
20 min
8.
Maintenance
To ensure reliable operation, the product must be maintained in accor-
dance with the maintenance labeling or at least once a year.
e.g. 2016-07
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
9.
Troubleshooting
Note
For further information, see instructions for use of ELAN 4 electro control
unit GA800 (TA014401).
10. Technical Service
Danger to life of patients and users if the product
malfunctions and/or protective measures fail or are
not used!
DANGER
►
Do not perform any servicing or maintenance
work under any circumstances while the product
is being used on a patient.
►
Do not modify the product.
Modifications carried out on medical technical equipment may result in
loss of guarantee/warranty rights and forfeiture of applicable licenses.
►
For service and repairs, please contact your national B. Braun/Aesculap
agency.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen /Germany
Phone:
+49 7461 95-1601
Fax:
+49 7461 14-939
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.
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