Bowa TissueSeal COMFORT, Instructions For Use Manual

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7 Preparation
30 TissueSeal / TissueSeal PLUS COMFORT MN031-543-S0 EN
7.7. Autoclaving

Autoclave the handle only in the unlatched position.
NOTE
Risk of destruction of the ligation instrument from hot-
air sterilization

Use a suitable sterilization method.
Use only steam sterilization with the following specifications:

Fractional vacuum method (with adequate device drying)

Compliant with EN 13060 or EN 285

Validation in accordance with EN ISO / ANSI AAMI ISO 17665
(formerly EN 554 / ANSI AAMI ISO 11134) (with applicable
IQ/OQ (commissioning) and product-specific performance
assessment (PQ))

Maximum sterilization temperature 134 °C plus tolerance in
accordance with EN ISO / ANSI AAMI ISO 17665 (formerly EN
554 / ANSI AAMI ISO 11134)

Minimum sterilization time 20 minutes at 121 °C or 5 minutes at
132 or 134 °C
Using the less effective gravitation method must be secured
by means of additional validation (longer sterilization times
may be necessary).
The manufacturer accepts no responsibility whatsoever for the use of
other sterilization methods, such as sterilization using ethylene oxide,
formaldehyde, radiation or low-temperature plasma.