3M Steri-Vac GSX Series - 11�4� Creating a Cycle in the 3 M Cycle Programmer

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3M
™
Steri‑Vac
™
Sterilizer / Aerator GSXSeries – Operator’sManual
11.4.Creating a Cycle in the 3M™ CycleProgrammer
DANGER: To reduce the risks associated with exposure to ethylene oxide:
Short term exposure limits (STEL) or long term exposure limits (LTEL,) or immediately dangerous to life or health (IDLH) limit could be exceeded during NORMAL use. Operators and
staff must use protective measures (e.g. engineering controls, work practices, or personal protective equipment (PPE)) in accordance with United States 29CFR 1910.134and 29CFR
1910.1047under NORMAL use conditions until the user’s facility management completes an exposure assessment on each custom cycle validating facility protective measures meet
national, state, and local requirements for short term exposure limits (STELs) and long term exposure limits (LTELs).
CAUTION: To reduce risks associated with exposure to potentially non‑sterile devices or inadequate sterilization procedures:
The user must validate the sterile efficacy of each custom cycle intended to sterilize products labeled ‘Sterile’.
1� Each time the 3M Cycle Programmer is opened, the user must be aware that Flushing and Aeration stages affect occupational exposure levels of ethylene oxide (EO), therefore the user must
acknowledge this safety feature prior to creating or modifying a custom EO cycle. (Figure37).
Read all DANGERs: To reduce the risks associated with exposure to ethylene oxide and read sections on defining set points for cycle stages specifically for the Flushing and Aeration
stages of the cycle (Chapter11, Sections 11.5.8and 11.5.9) prior to running custom cycles with ethlyeneoxide.
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Set points in the Flushing and Aeration stages can aect occupational exposure levels to
ethylene oxide.
Refer to the 3M™ Steri-Vac™ Sterilizer / Aerator GSX Series Operator Manual for additional
information.
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Figure37.
Acknowledging Importance of Flushing
and Aeration Stages SetPoints