Invuity ST2B Instructions For Use Manual page 5

The following sterilization parameters have been validated for instruments in a tray, wrapped or
unwrapped.
Note: Invuity endorses the following sterilization parameters per AAMI recommendations for
wrapped instruments and container with combined weight of less than 25 lbs [11.3 kg].
Sterilization
Note: Do not use Sterrad® or other sterilization processes that contain chlorine (bleach) or
enzymatic solutions.
The final responsibility for verification of sterilization techniques lies directly with the hospital. To
ensure the efficacy of hospital processing, all cycles and methods should be verified for different
sterilization chambers, wrapping methods, and/or various loading configurations.
International sterilization parameters are per the following standards:
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•
•
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Storage Store Sterilization Trays in a clean, dry area.
IFU 14466 Rev A
Description
Temperature
Cycle Time
Dry Time
Maximum exposure time may be extended to 18 minutes.
1
2 Maximum sterilization temperature may be extended to 137 °C.
Australia/New Zealand per AS/NZS 4187
Netherlands per Field Standard for Loaner Instruments, Rev 03.02, April 2008
Europe and the United Kingdom per EN ISO 17664
Canada per CSA ISO 17664
Steam Sterilization Parameters
Gravity
Displacement
132°C 2
(270°F)
15 minutes
1
45 minutes
Pre-Vacuum
132-138°C
(270-280°F)
3-8 minutes
1
30 minutes
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