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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 19101047) 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 (ie a sweet and irritating solvent smell)
4.1. Dangers
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) levels could be exceeded during NORMAL use The user’s facility
management is responsible for providing Operators, staff, and personnel working with 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series equipment comprehensive instructions in the process
This instruction includes information on relevant health hazards
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 (eg engineering controls, work practices, or personal protective equipment (PPE)) in accordance with United States 29 CFR 1910134 and 29 CFR
19101047 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)
Ensure Operator selects the correct cycle for the intended application
Ensure a minimum of ten (10) air exchanges per hour (ACH’s) for the room in which the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX 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
For reusable device sterilization, always follow device manufacturer’s instructions for use (IFU), including device cleaning, drying, packaging, sterilizing, and aerating
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 GSX 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) or as programmed by the Operator
Do not operate the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX 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 05 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
