WORLD OF MEDICINE A127, Инструкция по эксплуатации

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Care and Maintenance
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9.5.2.6 Reinstalling the Membrane
Reinstalling membrane before sterilization (see Fig. Pressure chamber membrane
and its position in the inflow tube set [
} 41]): Place the lip of the membrane (3)
into the ring groove
(4)
of the pressure chamber. The strap
(6)
must be positioned
in the notch
(5)
provided for this purpose. Press the lip of the membrane into the
groove
(4)
. A properly inserted membrane is flush with the pressure chamber and
exhibits no wrinkles.
9.5.2.7 Packaging
Pack the reassembled, dry product (see Chapter Reinstalling the Membrane [
}
44])
in disposable sterilization packaging (single or double packaging) which meets the
following requirements (material/process):
• Conform to EN ISO 11607-1 and -2 /ANSI AAMI ISO 11607-1 and -2.
• Suitable for steam sterilization (temperature resistance up to at least 142 °C
(288 °F) with sufficient steam permeability).
• Sufficient protection of the product or the sterilization packaging against
mechanical damage (e.g., from the spikes).
9.5.2.8 Sterilization
Only a clean, dry and disinfected as well as correctly assembled product (see
Chapter Subsequent Drying [
} 43], Chapter Reinstalling the Membrane [ } 44] and
Chapter Packaging [ } 44]) may be sterilized. Only the sterilization procedures lis-
ted below are to be used for sterilization. Other sterilization methods are not per-
mitted.
Steam Sterilization
• Fractionated vacuum process with at least three vacuum steps (with sufficient
product drying >20 minutes).
• Steam sterilizer according to EN 13060 and EN 285. ANSI AAMI ST79.
• Validated according to EN ISO 17665-1 (valid commissioning (installation/op-
erational qualification/IQ/OQ, and product-specific performance evaluation
(PQ).
• Maximum sterilization temperature 138 °C (280 °F; plus tolerance according to
EN ISO 17665-1).
• Sterilization time (exposure time at sterilization temperature) between 5 and
18 min (for prion deactivation) at 132 °C (270 °F)/134 °C (273 °F).
Use of the less effective gravitation procedure is allowed only in case of non-avail-
ability of the fractionated vacuum procedure; requires significantly longer steriliza-
tion times and must be validated specifically for the products, devices, and para-
meters in sole responsibility of the user.
The actual required drying time depends on parameters, which are the sole re-
sponsibility of the user (loading configuration and density, sterilizer condition, etc.)
and must therefore be determined by the user. However, drying times should never
be less than 20 minutes.
CAUTION!
Drying time
The indicated drying time depends on several variables, including the following:
Altitude, humidity, type of packaging, preconditioning, size of chamber, mass of
load, and placement in chamber. Users must verify that the drying time set in their
autoclave results in dry surgical equipment when using the method of saturated
steam sterilization described here.
Other sterilization methods The flash sterilization process is generally not permitted.
Do not use hot air sterilization, radiation sterilization, formaldehyde or plasma
sterilization.
Individual automated processing methods must be independently validated by the
operator.
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