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ENGLISH

FB-618/AU – rev.E – ed.2019/08

32/48

For Endochuck file holder:

• Reinstall the small O-ring (gasket) first, and then gently screw the retention bolt without

tightening it.

For any Instrument having its CombiTorque:

• Reinstall the Instrument on the CombiTorque.

Any EMS part can be correctly packaged using the following validated procedure:

• Single or Double Pouches suitable for Pre-Vacuum Moist Heat Sterilization compliant with

ISO 11607-1, or EN 868 resistant to 138°C and having adequate steam permeability (e.g.

Wipak STERIKING flat rolls Type R43 and R44).

Sterilization

Sterilization must be performed immediately after cleaning-disinfection.

DO NOT exceed the maximum number of sterilization cycles allowed.

DO NOT exceed a sterilization temperature of 138°C and a holding time of 20 minutes.

DO NOT use hot-air sterilization and radio-sterilization procedures: they destroy the products.

Moist heat sterilization of parts shall be performed according to ISO 17665 and under consideration

of the respective country requirements.

The following validated Pre-vacuum Moist Heat (steam) process can be used with any EMS part

packaged in appropriate single or double pouches:

Parameters for the Pre-vacuum Moist Heat cycle:

• 3 pre-vacuum phases

• Sterilization temperature of 132°C

• Pressure of 3 bar (absolute pressure)

• Humidity of 100%

• Holding time of 3 minutes minimum (full cycle)

• Drying time of 20 minutes minimum

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