8 Reprocessing
BOWA-IFU-MN031-554-ERGO315R-S3-EN-20210219
43
8.8.
Autoclaving
NOTE
Risk of destruction of the vessel sealing instrument from
hot-air sterilisation!
Use a suitable sterilisation method.
Use only steam sterilisation with the following specifications:
•
Fractional vacuum method (with adequate device drying)
•
Steam steriliser compliant with EN 13060 or EN 285
•
Validation in accordance with EN ISO /
ANSI AAMI ISO 17665 (formerly EN 554 / ANSI AAMI
ISO 11134) (valid IQ/OQ (commissioning) and
product-specific performance assessment (PQ))
•
Maximum sterilisation temperature 134°C (137°C incl.
tolerances of the steam steriliser according to EN 13060
or EN 285), including tolerance according to EN ISO/ANSI
AAMI ISO 17665 (formerly EN 554/ ANSI AAMI ISO 11134))
•
Sterilisation time
3
:
•
20 minutes at 121°C
•
3
– 20 minutes at 132/134°C
If the less effective gravitation sterilisation method is used
additional validation is required and longer sterilisation times
may be necessary.
The manufacturer accepts no responsibility whatsoever for the use of other
sterilisation methods, such as sterilisation using ethylene oxide,
formaldehyde, radiation or low-temperature plasma.
1.
Observe the following if such methods are used:
•
EN ISO 14937 / ANSI AAMI ISO 14937,
•
Standards relevant to the method.
2.
Verify the suitability and effectiveness of the method, taking into
account the specific product geometry in the context of
validation (including investigation of sterilisation medium
residues if appropriate).
3
Validation: Half cycle with 3 pre-vacuum phases at 132°C for 1.5 minutes,
Packaging: double in sterilisation foil
Summary of Contents for ERGO 315R
Page 1: ...MN031 554 S3 en Instructions for use...
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