Case Medical SteriTite Instrucciones De Uso página 9

Gravity Displacement IUSS Sterilization: Use only perforated bottom container. Attach FlashTite valve
plate(s) over all vents. No filter is used. Recommended parameters are a minimum of 5 minutes exposure
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for non-porous items at 270°F (132°C) and minimum of 10 minutes exposure for porous items, lumens and
mixed loads at 270°F (132° C). Recommended dry time: 0- 3 minutes dry time in the autoclave for items
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processed in flash sterilization depending on the degree of dryness required.
Note: Do not use the FlashTite valve with SteriTite® perforated bottom models SC04HG, SC04QG and
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SC04FG, because of height restrictions within these containers. Do not use solid bottom SteriTite®
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Container with FlashTite valve in gravity displacement IUSS sterilization.
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FLASHTITE REPROCESSING INSTRUCTIONS:
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After each use, disassemble and decontaminate the FlashTite valve plate with a multi-enzymatic, pH neutral
detergent as you would any SteriTite® component part. Thoroughly rinse and dry.
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Note: The copper module within the FlashTite valve mechanism will darken over time. This color change
will not impact the safety and effectiveness of the device.
Refer to the sterilizer manufacturer's "Instructions for Use" for specific information as to the limitations of
instrumentation, specifications and material compatibility. Complex instruments should be prepared and
sterilized according to the instrument manufacturer's instructions. Contact the manufacturer of your
endoscope or lumened devices when flashing.
Caution: When abbreviated dry time is implemented, moisture is present. Use a glove or towel when
transporting hot items from the autoclave. Do not mix the FlashTite valve plate(s) with the filter retention
plate(s) and disposable filter(s). Do not use the FlashTite valve plate(s) for EO or other low temperature
sterilizers including gas plasma (STERRAD) sterilization.
Note: For low temperature sterilizers refer to the information provided below.
SteriTite® Labeling for Low Temperature Sterilization
Intended Use: Low temperature sterilization is utilized for moisture and temperature sensitive devices. Each
sterilization modality has specific cycles and cleared for devices that are deemed compatible. Review the
cycle parameters and compatibility statement from the sterilizer and device manufacturer. SteriTite
Containers and MediTray products are universal reusable sterilization packaging systems validated for
compatibility with low temperature sterilizers and for devices such as instrumentation including flexible
endoscopes as follows:
STERRAD PARAMETERS FOR USE:
Use nonwoven polypropylene disposable filters: PolyPro filter # SCF02 (7.5" diameter) and SCFM02 (10"X4")
are a disposable filter supplied non-sterile. In STERRAD 100, 100S & 200 process only stainless steel
lumened instruments of 3mm diameter or larger and a length up to 400 mm. In STERRAD NX standard cycle,
process stainless steel lumened instruments of 2mm diameter or larger and up to 400 mm in length. In
STERRAD NX advanced cycle, process stainless steel lumened instruments of 1mm diameter or larger and
up to 500 mm in length and porous lumens (flexible endoscope) of 1mm diameter or larger and up to 850
mm in length. In the STERRAD 100NX Standard cycle, process stainless steel lumened instruments of 0.7mm
diameter or larger and up to 500mm in length. In STERRAD 100NX Flexible cycle, process flexible
endoscopes, and lumened instruments of > 1.2mm x < 835 mm. STERRAD Systems have pre-programmed
cycles for each unit.
Cycle time: The sterilizer manufacturer determines STERRAD® Sterilization cycle time.
Caution: In STERRAD® Sterilization do not use materials made of cellulose (paper filters and cotton) with
SteriTite® containers.
Compatibility: In STERRAD® Sterilization use only compatible materials and instruments as stated in the
Reference STERRAD® Operating Manual. Consult with your instrument manufacturer as to the compatibility
of various materials in STERRAD ® Sterilization. Refer to STERRAD® System Operating Manual, instructions
for use and labeling.
Internal Stacking: MediTray® baskets and trays may be stacked within the SteriTite® Container system as
follows: In STERRAD NX up to two (2) instrument baskets or trays may be stacked within the SteriTite®
container. In the STERRAD 200 up to four (4) instrument baskets or trays may be stacked. In STERRAD 200
& NX, the following MediTray baskets are not intended to be stacked: BSKF04, BSKF06, BSKH04, BSKQ04,
and BSKQ06. In addition, MediTray® insert boxes are not intended to be stacked. Case Medical recommends
that its Containers be placed flat on the sterilizer shelf.
External stacking was not tested. For STERRAD 100, 100S, 200 & 100NX: All models of SteriTite Containers
can be placed on each of the two shelves within the STERRAD® 200. However, only one shelf can be used
Copyright 2020 Case Medical, Inc.®
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IFU-CASETRANS Rev. 004A