Braun Aesculap ELAN 4, Manual

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12
Aesculap
®
ELAN 4 air motor hose 3 m with hand control GA706R or ELAN 4 air motor
hose 5 m with hand control GA707R, ELAN 4 air wall adapters GA710R to
GA715R
7.8 Wipe disinfection
RT: Room temperature
Phase I
►
Remove any visible residues with a disposable disinfectant wipe.
►
Wipe all surfaces of the optically clean product with a fresh, disposable
disinfectant wipe.
►
Observe the specified application time (1 min minimum).
7.9 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.
►
Set aside the product if it is damaged.
7.10 Packaging
►
Always follow the instructions for use of the respective packaging and
storage devices (e.g. instructions for use TA009721 for Aesculap-
ECCOS holder system).
►
Place the product in the correct position on the ECCOS holder GB053R,
see Fig. B and Fig. C.
►
Pack trays appropriately for the intended sterilization process (e.g. in
Aesculap sterile containers).
►
Ensure that the packaging will prevent a recontamination of the pro-
duct.
7.11 Steam sterilization
►
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
– 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 -6 , Aesculap recommends the
following parameters:
*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.
7.13 Storage
►
Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
Phase Step T
[°C/°F] t
[min] Conc.
[%] Water quality Chemicals
I Wipe disinfection RT
≥
1 - - Meliseptol HBV wipes 50 % Propan-1-ol
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization
method Temp. Time Minimum drying time
Prevacuum 270 °F/275 °F 4 min 20 min