The packing is to be marked with information about kind and date of the
sterilization, expiration date and batch.
13.2 STERILIZATION
An insufficiently cleaned Deflector Shaft is not allowed to be sterilized because
the effectiveness of the sterilization is depending on the quality of cleaning and
disinfection! Make sure that the instrument, especially its joints and covered
surfaces are clean.
The user is responsible for performing the specified sterilization
process with regard to achieving the desired or required steri-
lization effect.
STEAM STERILIZATION/AUTOCLAVING
• Information concerning validation and ISO standards in accordance with
DIN EN ISO 17665 (previously: DIN EN 554/ANSI AAMI ISO 11134) –
(valid IQ/OQ (commissioning) and product-specific provision of services (PQ))
• maximum sterilization temperature 138°C (280 °F; plus tolerance in
accordance DIN EN ISO 17665 (previously: DIN EN 554/ANSI AAMI
ISO 11134))
• steam sterilizer in accordance with DIN EN 13060 or DIN EN 285
Sterilization
Temp. °C
method
132°C
Pre-vacuum
134°C
135°C
Prion
134°C
Program
CAUTION
• Other autoclavation settings and cycles may have a negative impact on the
device or its components.
• The sterilized item must be dry after cooling down to room temperature.
Above mentioned drying time is mandatory.
• Please note that sterilization success may be decreased when overloading
the sterilizer. Also, unwelcome condensation with risk of rust is caused from
overloading. Please follow the recommendation of the sterilizer manufacturer.
• We recommend not to use other sterilization procedures (e.g. gravitation pro-
cedure, high-speed sterilization, hot-air-sterilization, radiation sterilization,
formaldehyde or ethylene-oxide sterilization, plasma sterilization).
• Observe the valid national legal regulations.
Temp. °F
Temp. holding time
270°F
4 min
273°F
3 min
275°F
3 min
273°F
18 min
Drying
time
20 min
20 min
20 min
20 min
21