3M Steri-Vac GS Series, Operator'Smanual

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3M ™ Steri-Vac
™
Sterilizer / Aerator GS Series – Operator’s Manual
4. Dangers and First Aid
DANGER: Potential health effects of ethylene oxide
Users in the United States must follow the requirements of the United States Occupational Exposure Standard for Ethylene Oxide OSHA (29 CFR 1910.1047). 100% ethylene oxide (EO) CAS
number 75-21-8 is a colorless gas at ambient conditions. Do not rely on sense of smell for the detection of ethylene oxide. EO has a high odor threshold and can only be detected by sense of
smell when it exceeds 500 - 750 parts per million (PPM). EO has a characteristic ether-like odor (i.e. a sweet and irritating solvent smell).
4.1. Dangers
DANGER: To reduce the risks associated with exposure to ethylene oxide:
Ensure a minimum of ten (10) air exchanges per hour (ACH’s) for the room in which the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series is installed.
Inspect display screen and cycle reports for error codes and listen for audible notifications (if enabled). Always take action for error codes as indicated in this manual.
Always follow device manufacturer’s instructions for use (IFU), including device cleaning, drying, packaging, sterilization, and aeration.
Do not overload the sterilization chamber. Use good practices for loading the sterilizer chamber.
Never use force to access the inside of the sterilization chamber.
Always review the elapsed aeration time on the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series display prior to opening the sterilizer door.
Always inspect cycle reports (printout or electronic) to ensure the total aeration time matches the device manufacturer’s instructions for use (IFU).
Do not operate the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series outside specified environmental conditions as stated in this manual.
Only use 3M™ Steri-Gas™ EO Gas Cartridges as listed in this manual. Do not use other brands or types of sterilant cartridges.
Do not force the 3M™ Steri-Gas™ EO Gas Cartridges into the cartridge holder as excessive force could damage the cartridge and result in a cartridge leak.
Do not use damaged 3M™ Steri-Gas™ EO Gas Cartridges.
If an individual 3M™ Steri-Gas™ EO Gas Cartridge is ever dropped, the cartridge should be used immediately or disposed of as described in the cartridge disposal section of this manual.
Sterilize only medical devices manufactured with materials compatible with ethylene oxide (EO) sterilization processes. Do not sterilize leather, liquids, or materials reactive to EO.
Ensure that the compressed air supply is clean, with a maximum allowable dirt particle size of 0.5 microns, and that the air supply is free of oil. Ensure that the air filters on the compressed air
supply contain a water trap and are cleaned daily (if applicable) and are properly maintained.
Call 3M Health Care service personnel or authorized 3M service personnel immediately if there is a failure of the display or backlight and the sterilizer continues to operate.
It is the user’s facility management’s responsibility to ensure that all personnel working with toxic chemicals, gases, and vapors are given comprehensive instruction in their use. This manual
includes information on relevant health hazards, national regulations, methods for safe use, and methods to detect escape of the agent.
It is the user’s facility management’s responsibility to ensure regular training of all personnel involved with the operation and maintenance of the equipment, including emergency
procedures for any toxic, flammable, or explosive material released into the environment and to maintain records of attendance and document evidence of demonstrated understanding from
training sessions.