Sterilization For The Us Market; Storage; Maintenance - Braun Aesculap Acculan 3Ti Instrucciones De Manejo

®
Aesculap Acculan 3Ti
Acculan 3Ti small drill GA671
Note
Prior to sterilization, remove all accessories, especially
the rinsing adapter, the Kirschner wire protection
sleeve, attachments, covers, etc!
►
Check to ensure that the sterilizing agent will come
into contact with all external and internal surfaces
(e.g. by opening any valves and faucets).
►
Validated sterilization process
– Disassemble the instrument
– Steam sterilization through fractionated vac-
uum process
– Steam sterilizer according to DIN EN 285 and
validated according to DIN EN ISO 17665
– Sterilization using fractionated vacuum pro-
cess at 134 °C/holding time 5 min
►
When sterilizing several instruments at the same
time in a steam sterilizer, ensure that the maxi-
mum load capacity of the steam sterilizer specified
by the manufacturer is not exceeded.

5.12 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
recommends the following parameters:
Aesculap Orga Tray/Sterile container (perforated
bottom)
Minimum cycle parameters*
Steriliza- Temp.
tion method
Prevacuum 270 °F/
275 °F
22
-6 , Aesculap
Time Minimum
drying
time
4 min 20 min
*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 products.
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.

5.13 Storage

►
Store sterile products in germ-proof packaging,
protected from dust, in a dry, dark, temperature-
controlled area.
6.

Maintenance

To ensure reliable operation, the product must be
maintained once per year as indicated on the mainte-
nance label, see Fig. 15, e.g. in February 2012.
Fig. 15
For technical service, please contact your national
B. Braun/Aesculap agency, see Technical Service.