zebris ARCUSdigma 3, Руководство пользователя

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Please note that all components are delivered UNSTERILE.
The following sterilization procedure should be used before use.
All components that come into contact with the patient‘s mucous
membranes (semicritical contact) must be sterilized before each use.
Maximum sterilization temperature 134 °C - 137°C (273°F / 278°F).
Tolerance according to DIN EN ISO 17665
Area Method Verfahren Temperature Minimum
holding time
USA Steam sterilization Vacuum method
(3x fractionated
pre-vacuum)
Drying time
minimum 20 min
132°C
(270°F)
4 minutes
Other countries Steam sterilization Vacuum method
(3x fractionated
pre-vacuum)
Drying time
minimum 20 min
132°C / 134°C
(270°F / 273°F)
5 minutes
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7.4.6 Packaging
Place the cleaned and disinfected components in sterile single-use packaging
that comply with the following requirements:
●
EN/ISO/ANSI AAMI ISO 11607 (for the USA: FDA approval).
●
Suitable for steam sterilization (temperature resistance to at least 142°C,
Sufficiently penetrable by steam).
●
Sufficient protection of the components as well as the sterile packaging against
mechanical damage.
7.4.7 Sterilization
For sterilization, please use only the listed sterilization methods
Steam sterilization
●
Fractionated vacuum process
●
Autoclave according to EN 13060/EN 285 or ANSI AAMI ST79 (for the USA: FDA approval).
●
Validated according to EN ISO 17665 valid IQ/OQ [commissioning] and product-specific
performance assessment [PQ])
●
Sterilization time (exposure time at sterilization temperature).