Page 7 of 25
L011-61
Rev. F0
2019-08-08
Sterilization
WARNING:
Users should be aware that the effects of unvalidated sterilization protocols could result in damage to
the components and affect their functioning or performance. The components of this system are not validated for
use with alternative sterilization protocols, and FHC does not recommend or endorse their use. Users with questions
regarding this safety issue should contact FHC’s Technical Service Department at 1-207-666-8190.
WARNING:
The microTargeting™ Platform is shipped non-sterile and must be sterilized before use. Invert the
platform on its hub surface with the legs pointing up during sterilization.
WARNING:
Disposable surgical kit is not intended for sterilization.
Platform and Drape Support Sterilization Instructions
Method
Steam
Protocol
Sterrad™
Sterrad™ 100S full cycle
Gravity wrapped
(in 2 layers of 1-ply polypropylene wrap
[3]
)
Exposure Time: 30 minutes at 132°C (270°F)
Minimum Dry Time: 60 minutes
[3] Cycle was validated using Halyard Health H300 wrap
Prevacuum wrapped
(in 2 layers of 1-ply polypropylene wrap
[4]
)
Preconditioning Pulses: 3
Exposure time: 4 minutes at 132°C (270°F)
Minimum Dry Time: 60 minutes
[4] Cycle was validated using Halyard Health H400 wrap
Method
Steam
Protocol
Gravity wrapped:
(in 2 layers of 1-ply polypropylene wrap
[1]
)
Exposure time: 10 minutes at 132°C (270°F)
[1] Cycle was validated using Halyard Health H600 wrap
Prevacuum wrapped:
(in 2 layers of 1-ply polypropylene wrap
[2]
)
Preconditioning Pulses: 3
Exposure time: 4 minutes at 132°C (270°F)
Minimum Dry Time: 40 minutes
[2] Cycle was validated using Halyard Health H200 wrap
Components in SteriSuite Case Sterilization Instructions
Prevacuum wrapped
(in 2 layers of 1-ply polypropylene wrap
[1]
)
Preconditioning Pulses: 3
Exposure time: 18 minutes at 134°C
Minimum Dry Time: 60 minutes
[1] Cycle was validated using Halyard Health H3 00 wrap
