Bowa TissueSeal PLUS Instrucciones De Uso página 81

7.7.
MN031-443-S0-20110112-EN
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).
TissueSeal / TissueSeal PLUS
7 Preparation
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