Henry Schein MAXIMA Bedienungsanleitung Seite 7

RE-PROCESSING
• Corrosion;
• Discolouration.
Numerical restrictions on reuse are listed under "Reusability".
Instruments that are still contaminated must be cleaned and
disinfected again.
Maintenance
Warning: Instrument lubricants must not be used.
Packing
If using an endo box, please follow the manufacturer's in-
structions. Then package the sterilisation trays and instru-
ments that do not fit in the interim stand (see Table 3) into
disposable sterilization pouches (disposable packaging) that
meets the following
requirements:
• Compliance with DIN EN 11607/ANSI AAMI ISO 11607;
• Suitable for steam sterilisation (withstands temperatures of
up to 142 °C (288 °F) or more, sufficient vapour permea-
bility).
Warning: Sterilisation in the sterilisation trays without
additional packaging is not permitted. The autoclave pa-
per in the boxes is for added safety only.
Sterilization procedure
Fractionated vacuum/ pre-vacuum method
Fractionated vacuum/ pre-vacuum method
Gravity method
Gravity method
Table 1 (outside the USA)
Sterilization procedure
Fractionated vacuum/
pre-vacuum method
Fractionated vacuum/
pre-vacuum method
Gravity method
Gravity method
Table 2 (USA)
1. The less effective gravity method should only be used if the fractionated vacuum method is not available.
2. The drying time that is actually required depends directly on parameters that are the sole responsibility of the user (loading configuration, how many items are loaded
and how closely together they are loaded, condition of the steriliser, etc.) and must therefore be established by the user. However, the drying time must never be less
than 20 minutes.
3. Or 18 min. (prion inactivation).
in Line with DIN EN ISO 17664/AAMI ST81
Sterilization temperature
134 °C (273 °F)
121 °C (250 °F)
134 °C (273 °F)
121 °C (250 °F)
Sterilization tempe- Minimum sterilization time / Expo-
rature sure time at sterilization temperature
132°C (270 °F) 4 minutes
121 °C (250 °F)
132°C (270 °F) 15 minutes
121 °C (250 °F) 60 minutes
Sterilization
Use only the sterilization methods listed below; other steriliza-
tion methods are not permitted.
Steam sterilisation:
• Fractional vacuum/pre-vacuum method (at least three vac-
uum cycles) or gravity displacement method1 with suffi-
cient product drying²;
• Steam steriliser in accordance with DIN EN 13060 or DIN EN
285, ANSI AAMI ST79;
• Validated in accordance with DIN EN ISO 17665 (valid IQ and
OQ plus product-specific performance qualification (PQ));
• Maximum sterilisation temperature of 138 °C (280 °F) must
not be exceeded; plus tolerance according to DIN EN ISO
17665;
• See Table 1 for outside the USA, Table 2 for the USA only.
Minimum sterilization time / Exposure
time at sterilization temperature
3 minutes³
20 minutes
5 minutes
60 minutes
Minimum drying time²
20 minutes
20 minutes
20 minutes