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13. Reprocessing guidelines
Recommended sterilisation cycles
Steam sterilisation
– Sterilisation time at least 3 minutes at 134°C
(273°F), 4 minutes at 132°C (270°F), 30 minutes
at 121°C (250°F)
– Maximum sterilisation temperature 135°C (275°F)
Evidence of the medical device’s basic suitability
for effective sterilisation was provided by an
independent test laboratory using the LISA 517
B 17L* steam steriliser (W&H Sterilisation S.r.l.,
Brusaporto (BG)), the Systec VE-150* steam
steriliser (Systec) and the CertoClav MultiControl
MC2-S09S273** steam steriliser ( CertoClav GmbH,
Traun).
“Dynamic-air-removal prevacuum cycle” (type B) /
“Steam-flush pressure-pulse cycle” (type S)*/**
– 134°C (273°F) for at least 3 minutes,
– 132°C (270°F) for at least 4 minutes
“Gravity-displacement cycle” (type N)**
– 121 °C (250°F) for at least 30 minutes
*EN 13060, EN 285, ISO 17665
**ANSI/AAMI ST55, ANSI/AAMI ST79
NOTE: All other sterilisation methods are not approved
and must not be used.
Storage
Store sterile goods dust-free and dry.
The shelf life of the sterile goods depends on the
storage conditions and type of packaging.
Before starting operation again, wait until the
motor and cable are completely dry. Moisture in the
motor or plug can lead to malfunction. (Risk of short
circuit)
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