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If necessary blow out with filtered compressed air. Only dry the products
with compressed air (< 3 bar) in order to avoid possible damage.
7.4 Inspection
Check the products for operation as well as visual damage according the
corresponding instructions for use. BOWA recommend that with moveable or
swivelling parts (e.g. forceps) instrument oil should not be used (exception:
surgical instruments made of stainless steel) due to the fact that certain
plastics tend to swell and owing to the oil even hinder movement.
7.5 Packing
Before sterilization, the disassembled instruments must be packed into a
suitable one-way sterilization packing (single layer or double layer packing)
and/or a suitable sterilization container:
•
according to DIN EN 868/ANSI AAMI ISO 11607
•
suitable for steam sterilization (temperature resistive up to 137°C,
sufficient steam porosity)
•
regular maintenance (sterilization container)
IMPORTANT
It is not permitted to sterilize in the transport packing.
7.6 Autoclaving
The instruments must only be sterilized in the disassembled condition. Only the
following sterilization methods are to be used for sterilization, other sterilization
methods are not permitted.
Steam sterilization
•
Fractionated vacuum method
•
Steam sterilizer according to DIN EN 13060 resp. DIN EN 285
•
According to DIN EN 554/ANSI AAMI ISO 11134 validated (valid
commissioning and specific product service assessment)
•
Maximum sterilization temperature 134 °C (plus tolerance according to
DIN EN 554/ANSI AAMI ISO 11134)
•
Sterilization time min. 20 min (at 121 °C) resp. 5 to 20 min at 132°/134
°C
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The use of a less effective gravitation method must be ensured by additional
validation (if necessary, longer sterilization times required).
The suitability of the product for effective sterilization was proven by BOWA
with the fractionate vacuum method with the above sterilization
times/temperature.
The confirmation of the basic suitability of the instruments for effective
steam sterilization was given by an independent accredited test laboratory
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BOWA-IFU-MN030-088-ARGON-HANDLES-AND-ELECTRODES-S6-ML-20230910
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(with sufficient product drying)
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