FDI P2131, Technical Manual, Page: 11 / 161

2.3 Sterilization Cycles – FDA Cleared
Cycle Recommended Use
Maximum
Load
Exposure
Temperature
1
(°F/°C)
Exposure
Time
(minutes)
Dry Time
(minutes)
Immediate
Use
(IUSS)
Unwrapped
nonporous
(e.g., instruments)
and porous items in
mixed loads
36 lbs. 270/132 4 0
Textiles Textile packs
3 textile
packs
2
270/132 4 5
3
Wrapped
Instruments
Wrapped
instruments/utensils
36 lbs. 270/132 4 20
3
Wrapped
Instruments
Wrapped
instruments/utensils
36 lbs. 270/132 10
4
20
3
Bowie ‐ Dick
Test
Test NA 273/134 3.5 0
Vacuum Leak
Test
Test NA NA
Test time
20
0
1
The AAMI minimum temperature is 270°F (132°C) for all cycles except Bowie ‐ Dick which is 273°F (134°C). The P2131
sterilizer setpoint temperature is 273°F (134°C) for all cycles except Bowie ‐ Dick which is 274°F.
2
AAMI standard 16 ‐ towel pack (9”x9”x6”).
3
Dry times are pre ‐ set to established standard conditions, but can be manually increased.
4
The FDA ‐ cleared Process Challenge Device (PCD) for this 10 ‐ minute cycle can be purchased from FDI at
(865) 408 ‐ 0100 or via email at sales@fortdefianceind.com . Reference Appendix A.3 for additional information
on this PCD.
WARNING : The P2131 sterilizer does not include a sterilization cycle for liquids. DO NOT
ATTEMPT TO STERILIZE ANY LIQUIDS .
5