Steam Sterilization - Kls Martin Group Sonicweld Rx Gebrauchsanweisung

Ultrasonic Unit SonicWeld Rx®
Instructions for Use

Steam sterilization:

• Fractionated vacuum procedure (with sufficient product drying
• Steam sterilizer according to DIN EN 13060/DIN EN 285/ ISO 14937 or ANSI AAMI ST79 (for the US: FDA
clearance)
• Validated according to DIN EN ISO 17665 (valid IQ/OQ (commissioning) and product-specific
performance evaluation (PQ))
• Maximum sterilization temperature 134°C (273°F; plus tolerance according to DIN EN ISO 17665)
Steam sterilization with fractionated pre-vacuum
Pre-vacuum cycles
Medium
Sterilization time
Sterilization temperature
Drying time
The basic suitability of the products for effective steam sterilization was demonstrated by an independent,
officially accredited and recognized (§ 15 (5) German Medical Devices Act) test laboratory using the steam
sterilizer Systec DX-45 (Clean Controlling Medical GmbH & Co. KG) and fractionated vacuum procedure.
Typical conditions in clinics and physicians' practices as well as the procedure described above were taken
into account.
Do not use gravitational sterilization, lightning sterilization, hot air sterilization, radiation sterilization,
formaldehyde sterilization, ethylene oxide sterilization or plasma sterilization.
Approved sterilization packaging (e.g. conforming to EN 868, ISO 11607) must be used for sterilization,
subsequent transportation and storage.
2 The actual drying time required depends directly on parameters which are the sole responsibility of the user (loading configuration and density,
sterilizer condition, ...) and must therefore be determined by the user. Nichtsdestotrotz sollten Trocknungszeiten von 20 min nicht unterschritten
werden.
3 or extended sterilization time (e.g. 18 min) for prion inactivation according to national specifications
Revision 04
Procedure 1
min. 3 x
saturated water vapor
3
Min. 2 min (or longer)
134°C, plus tolerance
20 min
2
2 )
Procedure 2
min. 3 x
saturated water vapor
Min. 2 min (or longer)
132°C, plus tolerance
20 min
2
3
75