Device Description; Intended Use - Case Medical SteriTite Instrucciones De Uso

Note: Case Medical recommends verification of these parameters in the health care facility given
variations in equipment, steam quality and environmental conditions. To reduce condensate formation,
crack the autoclave door for 10 to 15 minutes to allow gradual cool down.
Caution: Visible signs of moisture may be indicative of a sterilization process failure and may impact
barrier performance of the container. If this occurs, it is recommended to repackage and re-sterilize with
a longer dry time. Limits of reuse: If visible signs of wear are present, such as cracking, peeling,
rust/corrosion or discoloration, the Container should be discarded.
PRE-VACUUM IMMEDIATE USE STEAM STERILIZATION: Use vented or solid base Container for pre-vacuum
steam "IUSS" sterilization. IUSS sterilization is for immediate use only. Moisture may occur in IUSS cycles.
Caution: Use a glove or towel when transporting hot items from the autoclave. Recommended exposure
time: 4 minutes at 270°F (132°C) with 0-3 min dry time. User may add additional dry time for a drier
outcome. Disposable paper filter SCF01 (7.5" diameter) and SCFM01 (10"X4") are supplied nonsterile.
Note: The user should contact their device manufacturer for appropriate (extended) sterilization cycle
conditions. (ANSI/AAMI ST 79:2006 – Comprehensive guide to steam sterilization and sterility assurance in
health care facilities).
TABLE TOP PRE-VACUUM STEAM STERILIZATION: SteriTite® Containers can be used in small table top
sterilizers with dynamic air removal. Container sizes are limited due to the small chambers of the table
top sterilizers.
GRAVITY DISPLACEMENT STEAM PARAMETERS FOR USE: Use only perforated base Containers for gravity
displacement steam. Use MediTray basic trays. Select the appropriate exposure time based on load and
size of container. Recommended minimum exposure time: 30 minutes at 250°F. Use of sealed Containers
may require additional exposure time in gravity displacement steam.
Stack ability of SteriTite® Containers in Steam Sterilization: Up to three (3) Containers can be stacked and
processed in the autoclave.
WARNING: Prepare complex instruments according to the instrument maker's instructions. Use of
nonabsorbent tray liners can cause condensate to pool. Do not use peel pouches within sealed containers,
as they cannot be placed on their side for sterilization.
SteriTite® Labeling for FlashTite®
DEVICE DESCRIPTION: The SteriTite® Container may be used as a filter-less sterilization packaging system
when FlashTite valve plate(s) are utilized for steam sterilization.
attachments to the SteriTite® rigid reusable sealed Container for pre-vacuum IUSS (flash) and gravity
displacement IUSS (flash) steam sterilization cycles and are used in place of a disposable filter and its
associated filter retention plate(s).
INTENDED USE: The SteriTite® sealed Container with FlashTite valve plate(s) is intended to be used for
sterilization of one instrument or instrument set in immediate IUSS sterilization.
Note: Flashed items are for immediate use only, per AAMI guidance. Product was tested for sterility
maintenance for 24-hour shelf life. The FlashTite valve is recommended for one (1) year of use or 400 cycles.
Record date of first use for your records.
LOAD: The contents must be placed within an instrument basket or tray. FlashTite systems for gravity
displacement steam sterilization require a load restricting basket designed to clear the FlashTite valves
placed on the lid and on the base. Either perforated bottom or solid bottom SteriTite® Containers may be
used with FlashTite valve plate in pre-vacuum IUSS sterilization. Use MediTray® basic trays for IUSS
sterilization cycles. The SteriTite® solid bottom Containers including 4" high models may be used for IUSS
sterilization with FlashTite valve plate(s) in lid.
FLASHTITE PARAMETERS FOR USE:
Pre-vacuum Immediate Use Steam Sterilization (IUSS): Use either vented or
solid base Container with the same number of FlashTite valve plate(s) as the
number of vents. Recommended parameters are 4 minutes exposure at 270°F
(132°C). Recommended dry time for SteriTite® Container with FlashTite valve
plate(s): 0- 3 minutes dry time in the autoclave for items processed in IUSS
(flash) sterilization depending on the degree of dryness required. Clean with
pH neutral detergent, rinse and dry after each use. To assemble FlashTite
valve rotate the latch clockwise. To remove rotate latch counter clockwise.
Copyright 2020 Case Medical, Inc.®
The FlashTite valve plate(s) are
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IFU-CASETRANS Rev. 004A
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