Sterilization; Storage; Reprocessing Validation Study Information - EMS AIR-FLOW Wiederaufbereitungshinweise

Products:

Sterilization:

Do not exceed the maximum
number of sterilization cycles.

Storage:

Reprocessing validation
study information
Additional Instructions: None
It is the duty of the user to ensure that the reprocessing processes including resources, materials and personnel are capable to reach the required
results. State of the art and often national law requiring these processes and included resources to be validated and maintained properly.
FB-594_rev_A-01_Not. Handy PaM Reprocessing.indd 5
HANDPIECE
Sterilization of instruments by applying a fractionated pre-vacuum process
(according ISO 13060 and ISO 17665) under consideration of the respective
country requirements.
Parameters for the pre-vacuum cycle:
3 prevacuum phases
Sterilization temperature of 132°C for 4 minutes
or
Sterilization temperature of 134°C for 3 minutes
Drying time: minimum 20 min
Don't exceed a sterilization temperature of 138°C and a holding time of 20 min.
or
Parameter for gravity-displacement steam sterilization:
Sterilization temperature 132°C for 15 minutes
Flash sterilization is not allowed on lumen instruments!
Storage of sterilized instruments in a dry, clean and dust free environment at modest temperatures
of 5°C to 40°C.
The following test devices, materials & machines have been used in this
validation study;
Cleaning agent: Neodisher® Mediclean (Dr. Weigert GmbH & Co. KG,
Hamburg).
Disinfection agent
For Handpiece FD 350 (from Dürr GmbH)
For instruments ID 212 (from Dürr GmbH).
Washer / Disinfector: Miele 7735 CD
Instrument Rack: Miele O177/1 and U874
Details: See report TFT-391/STE
HANDY
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