Inspection, Maintenance And Checks; Packaging; Steam Sterilization; Sterilization For The Us Market - B.Braun Aesculap GA553 Instrucciones De Manejo/Descripción Técnica

6.9

Inspection, maintenance and checks

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Allow the product to cool down to room temperature.
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Inspect the product after each cleaning and disinfecting cycle to be
sure it is: clean, functional, and undamaged.
►
Spray through the motor/handpiece with Aesculap STERILIT oil spray
GB600 with the appropriate adapter for approx. 1 s.
►
Check the product for any damage, abnormal running noise, overheat-
ing or excessive vibration.
►
Set aside the product if it is damaged.

6.10 Packaging

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Always observe the instructions for use of packaging and storage
devices.
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Insert the product in its proper position in the holder, or put it on a tray
in such a way that the product is protected against damage.
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Pack trays appropriately for the sterilization process (e.g. in Aesculap
sterile containers).
►
Ensure that the packaging will prevent a recontamination of the prod-
uct.

6.11 Steam sterilization

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Check to ensure that the sterilizing agent will come into contact with
all external and internal surfaces (e.g. by opening any valves and fau-
cets).
►
Validated sterilization process
– Disassemble the product
– Steam sterilization through fractionated 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 products at the same time in a steam sterilizer,
ensure that the maximum load capacity of the steam sterilizer speci-
fied by the manufacturer is not exceeded.

6.12 Sterilization for the US market

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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.

6.13 Storage

►
Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
7.

Maintenance

To ensure reliable operation, the product must be maintained at least once
a year.
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
-6 , Aesculap recommends the
Time Minimum drying time
4 min 20 min
9