Inspection, Maintenance And Checks; Packaging; Sterilization Method And Parameters; Sterilization For The Us Market - Aesculap GB740R Instrucciones De Manejo

Aesculap Power Systems
Craniotome handpiece GB740R and accessories

5.9 Inspection, maintenance and checks

Allow the product to cool down to room temperature.
Inspect the product after each cleaning and disinfecting cycle to be
sure it is clean, functional and undamaged.
Spray through the craniotome handpiece with Aesculap STERILIT® oil
spray GB600, using adapter GB600820, until clear oil emerges from the
handpiece.
Check the product for any damage, atypical running noise, overheating
or excessive vibration.
Inspect tools for broken, damaged or blunt edges.
Set aside the product if it is damaged.

5.10 Packaging

Always follow the instructions for use of the respective packaging and
storage systems (e.g. instructions for use TA009721 for the Aesculap
Eccos® storage system).
Insert the product in its proper position in the Eccos® holder, or put it
on a tray in such a way that the product is protected against damage.
Make certain that all cutting edges are protected.
Pack trays appropriately for the sterilization process (e.g. in Aesculap
sterile containers).
Ensure that the packaging provides sufficient protection against
recontamination of the product (DIN EN ISO 11607).

5.11 Sterilization method and parameters

Check to make certain that the sterilizing agent will be in contact with
all external and internal surfaces (e.g. by opening any valves and
faucets).
Validated sterilization process
– Steam sterilization through fractionated vacuum process
– Steam sterilizer according to DIN EN 285, validated according to DIN
EN/ISO 17665
– Sterilization through fractionated vacuum process at 134 °C/2 bar;
holding time 5 min.
When sterilizing several products at the same time in one steam
sterilizer: Make certain that the maximum allowable load capacity of
the steam sterilizer, as specified by the manufacturer, is not exceeded.
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5.12 Sterilization for the US market

• Aesculap does not recommend the device sterilized by flash or chemi-
cal sterilization.
• Sterilization may be accomplished by steam autoclave in a standard
prevacuum cycle.
To achieve a sterility assurance level of 10-6, Aesculap recommends the
following parameters:
Aesculap Orga Tray/Sterilcontainer (perforated bottom)
Minimum cycle parameters*
Sterilization Temp.
Time
method
Pre-vacuum 132 °C 4 min
(275 °F)
*Aesculap has validated the above sterilization cycle and has the data on
file. The validation was accomplished in an Aesculap Sterilcontainer
cleared by FDA for the sterilization and storage of these instruments.
Other sterilization cycles may also be suitable, however individuals or hos-
pitals 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 elim-
inate the risk of crosscontamination.

5.13 Storage

Store sterile products in germ-proof packaging under dust protection
in a dry, dark and temperature-controlled room.

6. Maintenance

Risk of burns, necroses and impaired functioning of
the craniotome reamer caused by hot blades!
Do not re-sharpen or manipulate the craniotome
WARNING
reamers.
To ensure reliable operation, Aesculap recommends servicing the product
as indicated on the service label.
e.g. 2011 - 02
For services to that end, please contact your national B. Braun/Aesculap
agency, see Technical Service.
Minimum drying time
20 min