3M Steri-Vac GS Series, Operator'Smanual

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11. Medical Device Packaging and Loading
11.1. Preparing Medical Devices for Sterilization
Clean devices for sterilizing according to the device manufacturer’s instructions for use before processing in the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series.
Thorough cleaning is essential to achieve sterilization efficacy.
The definition of a lumen as noted in the cleared Intended Use statement, is an opening or pathway into a medical device. Lumens have several configurations. A lumen may have only 1
opening into the device that serves as both the entrance and exit for sterilant penetration and contact. These are worst case lumens for effective gaseous sterilization. A lumen may also have 1
opening and 1 exit. These configurations are counted as 1 lumen. A lumen may also have multiple openings and multiple exits into and out of the device. These configurations are also counted
as 1 lumen. These configurations provide the sterilant multiple openings and exits for penetration and removal which allows for efficient gaseous sterilization. Per this definition, most common
gastrointestinal endoscopes have 2 or 3 lumens.
11.1.1. Preparing Endoscopes for EO Sterilization
NOTICE: To reduce the risk of endoscope damage:
Always follow the endoscope manufacturer’s instructions for use (IFU) for venting and preparing the endoscope for sterilization.
To prevent possible damage of the endoscope during the air removal or vacuum stages of the sterilization process, some models and brands of endoscopes require a method to vent the
endoscope. Venting the endoscope allows a balance of internal and external pressures during the vacuum phases of the sterilization process (i.e. ensuring the pressure inside of the endoscope
equilibrates with the vacuum of the chamber). Some brands and models of endoscopes may require:
• connecting a ventilation cap
• removal of the water resistant soaking cap
• both connecting a ventilation cap and removal of the water resistant soaking cap
In addition some brands and models require the removal of parts before packaging and sterilization. Always follow the endoscope manufacturer’s instructions for use (IFU) for venting and
preparing the endoscope for sterilization.
DANGER: To reduce risks associated with exposure to ethylene oxide:
Always follow the device manufacturer’s instructions for use (IFU), including device cleaning, drying, packaging, sterilizing, and aerating.
Only sterilize medical devices that are manufactured with materials compatible with ethylene oxide sterilization processes. Do not sterilize leather, liquids, or materials that are reactive to
ethylene oxide.
WARNING: To reduce risks associated with fire and explosion:
Do not sterilize devices with energy sources which could create a spark in the sterilization chamber during the sterilization cycle.
Always follow device manufacturer’s instructions for use (IFU), including device cleaning, drying, packaging, sterilization, and aeration.
CAUTION: To reduce patient risks associated with exposure to potentially non-sterile devices or inadequate sterilization procedures:
Always follow device manufacturer’s instructions for use (IFU), including device cleaning, drying, packaging, sterilization, and aeration.
Only sterilize medical devices that are manufactured with materials compatible with ethylene oxide sterilization processes. Do not sterilize leather, liquids, or materials that are reactive to
ethylene oxide.