52
3M
™
Steri-Vac
™
Sterilizer / Aerator GS Series
– Operator’s Manual
13. Process Monitoring and Load Release
CAUTION: To reduce patient risks associated with exposure to potentially non-sterile devices or inadequate sterilization procedures,
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).
All sterilization processes require a comprehensive quality control program that includes sterility assurance monitoring. Comprehensive monitoring of the 3M™ Steri-Vac™ Sterilizer/Aerator GS
Series consists of three essential elements:
1.
Monitoring of physical parameters (sterilizer cycle reports).
2.
Use of biological indicators (BIs) within the appropriate process challenge device (PCD) or Test Pack.
3.
Use of chemical indicators (CIs).
13.1. Physical Parameters and Requirements
DANGER: To reduce the risks associated with exposure to ethylene oxide,
always inspect cycle reports (printout or electronic file) to ensure the total aeration time matches the device manufacturer’s instructions for use (IFU).
CAUTION: To reduce patient risks associated with exposure to potentially non-sterile devices or inadequate sterilization procedures:
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.
The 3M™ Steri-Vac™ Sterilizer/Aerators GS Series is designed with embedded software that automatically controls and independently monitors the physical process parameters to ensure
sterilization conditions are maintained throughout the sterilization cycle. The sterilizer embedded software regulates, independently monitors, and records all critical sterilization process
parameters including pressure, temperature and percent relative humidity (%RH) in conditioning.
Documentation for physical parameters is provided on the 3M™ Steri-Vac™ Sterilizer/Aerator GS Series cycle reports (printout and electronic file). Under normal operating conditions, the paper
cycle report produced at the end of the cycle will be similar to the one shown in Figures 48 – 52.
Each cycle report should be reviewed prior to load release per facility policies. Critical parameters for the 38 °C and 55 °C cycles are contained in Table 6. Verification of these parameters on the
printed cycle report is illustrated in Figures 61 and 62. Verification of cycle performance should be conducted per facility policies. For all cycles confirm final status contains
Cycle Complete
on
the printout footer (Figure 62). There is space on the cycle report for a signature and date.
End time
on the cycle report footer is the date and time (month/day/4-digit year + hh:mm:ss) when the Stop button was pressed after cycle is complete.
Total cycle time
on the cycle report footer is the actual total elapsed time in hours and minutes (hh:mm) of the selected cycle. The Total cycle time is the duration between touching the cycle
Start button and when the Cycle Complete text appears on the display screen. If continuous aeration was selected, the Total cycle time is the duration between touching the cycle Start button and
touching the Stop button.
Cycle
Selected
Final Status
End of
Conditioning
Temp (°C)
End of Conditioning
(%RH)
EO
Exposure Time
(hr + min)
Aeration Temp (°C)
Aeration Time (min)
38°C
‘Cycle Complete’ + ‘No Errors’
38 ± 3
40 - 80
4.5 hr ± 5.4 min
As Programmed per
Manufacturers IFU
As Programmed per
Manufacturers IFU
55°C
‘Cycle Complete’ + ‘No Errors’
55 ± 3
40 - 80
1.0 hr ± 1.2 min
Table 6. Preprogrammed GS Series Cycle Report Physical Parameter Requirements
Summary of Contents for Steri-Vac GS Series
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