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10
3M
™
Steri‑Vac
™
Sterilizer / Aerator GSX Series
– Operator’s Manual
6 Cautions
CAUTION: To reduce the risk of injury:
Always follow the procedures described in this manual
Follow good ergonomic practices Loading baskets should not be overfilled requiring excessive force in pulling and pushing loaded baskets in and out of the sterilizer chamber Reference
facility policies and procedures for appropriate ergonomic practices
CAUTION: To reduce patient 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 that are labeled as ‘Sterile’
Ensure Operator selects the correct cycle for the intended application
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 use chemical indicators and biological indicators for monitoring the performance of sterilization cycles as described in this manual Always use chemical indicators and biological
indicators per the device manufacturer’s instructions for use (IFU)
Always inspect cycle reports (printout or electronic file) to ensure the Operator’s programmed parameters or the device manufacturer’s instructions for use (IFU) matches:
•
%RH at the End of Conditioning,
•
Temperature at the End of Conditioning,
•
Actual Gas Exposure Time
Complete maintenance at routine scheduled intervals of a maximum of every six (6) months There are no user‑serviceable parts Only use 3M Health Care service personnel or authorized
3M service personnel for maintenance
For reusable device sterilization, 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
Sterilize only medical devices manufactured with materials compatible with ethylene oxide (EO) sterilization processes Do not sterilize leather, liquids, or materials reactive to EO
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 Excessive force could damage the cartridge and result in a cartridge leak
Do not operate the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series outside the environmental conditions as stated in this manual
Immediately call 3M Health Care service personnel or authorized 3M service personnel if there is a failure of the display or backlight and the GSX Series sterilizer continues to operate
Do not modify any data or records from the sterilizer system which may lead to misinterpretation of physical monitor results
Do not place any device emitting strong electronic magnetic fields (EMFs) near the sterilizer