Case Medical SteriTite Instrucciones De Uso página 10

to accommodate an 8" high perforated base SteriTite® container, because of height restrictions within the
sterilizer's chamber. For STERRAD NX only 2",3" and 4" high Containers will fit in the sterilizer chamber.
MediTray® Products including MediTray® inserts, instrument baskets,
stacking trays, BackBone silicone brackets, stainless and aluminum
brackets, posts and partitions may be used in STERRAD Sterilization,
wrapped or containerized. Utilize white tamper evident seals, Polypro
filters and load cards available from Case Medical for H2O2 sterilization.
Caution: Do not use nylon coated brackets or silicone mat.
Do not use saline based water softener for the final rinse as it causes corrosion and aborted cycles.
Do not use alkaline cleaners to decontaminate the Container as it causes corrosion and aborted cycles.
EO PARAMETERS FOR USE:
EO Sterilization: SteriTite® Containers with disposable filter may be used in EO sterilization for sterilization
of blades and lumens. Solid bottom Containers may be used in EO pre-vacuum sterilizers.
Residual analysis shows that EO and EC limits were found to be well below maximum limits after 12 hours
post aeration at room temperature.
Recommended exposure time in 600 mg/liter EO gas mixture (90% CO2 / 10% EO) - 2 hours.
230 mg/liter EO gas mixture (91.5% CO2 / 8.5% EO) - 3 hours.
In EO sterilization, metal lumened devices of 2.2mm diameter or larger and length up to 457 mm and
porous lumened devices of 3mm diameter or larger and length up to 400 mm may be processed. Contact
your medical device manufacturer for specific processing information.
Stacking of SteriTite® Containers in EO sterilization: Up to three (3) SteriTite® Containers can be stacked
and processed in the sterilizer.
Note: Polymeric and porous materials may require extended EO exposure time. Items with lumens should
be thoroughly dried for EO sterilization.
TSO3 STERIZONE PARAMETERS FOR USE:
Use non-woven polypropylene disposable filters: Disposable nonwoven filter # SCF02 (7.5" diameter) and
SCFM02 (10"X4") are a single use disposable filter supplied nonsterile.
Use vented or solid base Container for STERIZONE® VP4 sterilization. Use MediTray® products in the
Container to secure instrumentation. Recommended for sterilization of medical devices, including flexible
endoscopes, full instrument sets and mixed loads, including general instrumentation (gliding mechanism,
hinges & screws, stopcock, lure-lock), instruments with rigid lumens (no dead-end) and rigid non-lumened
scopes. Sterilize instruments with diffusion restricted areas such as the hinged portion of forceps and
scissors and medical devices, including single/multi-channel rigid endoscopes with an internal diameter of
0.7mm or larger and a length of 500mm or shorter (up to twelve rigid channels in the presence of other
packaged medical devices). Sterilize up to three single channel surgical flexible endoscopes (one per
container, three Containers per load) with an internal channel diameter of 1.0mm or larger and a length of
850mm or shorter.
Cycle time: The sterilizer manufacturer determines STERIZONE® VP4 Cycle 1 Sterilization cycle parameters.
The cycle has a phase of hydrogen peroxide vapor exposure and one of hydrogen peroxide reduction using
Ozone.
Internal Stacking: Testing was done with up to four (4) stacked trays or baskets inside the containers.
Compatibility: Use only compatible materials and instruments as stated in the STERIZONE® VP4 Operating
Manual.
Compatibility: Consult with your instrument manufacturer as to the compatibility of various materials in
STERIZONE® VP4 Sterilization. Refer to TSO3 System Operating Manual instructions for use and labeling.
Caution: Do not use saline based water softener for the final rinse as it causes corrosion and aborted
cycles. Do not use alkaline cleaners to decontaminate the Container as it causes corrosion and aborted
cycles.
STERIS V-PRO PARAMETERS FOR USE: The SteriTite Container system is intended for use in Steris V-Pro1, V-
Pro1 Plus, and V-Pro Max. The container system is validated for a maximum load of 31 lbs. including
container and contents. Use non-woven polypropylene disposable filters: Disposable nonwoven filter #
SCF02 (7.5" diameter) and SCFM02 (10"X4") are a single use disposable filter supplied nonsterile.
Copyright 2020 Case Medical, Inc.®
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IFU-CASETRANS Rev. 004A
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