Sterilization - MicroAire Smart Release Instructions For Use Manual

INSTRUCTIONS FOR USE

STERILIZATION

Steam sterilize using one of the below cycles. The following steam parameters have been found to be successful in demonstrating a
sterilization assurance level (SAL) of at least 10-
GRAVITY-DISPLACEMENT STEAM
Exposure Time
Exposure Temperature
Minimum Dry Time
DYNAMIC AIR REMOVAL (Pre-Vac)
Exposure Time
Exposure Temperature
Minimum Dry Time
"FLASH" GRAVITY-STEAM
Exposure Time
Exposure Temperature
Minimum Dry Time
Note: Where there is a concern about TSE/vCJD contamination, the World Health Organization recommends processing through a
pre-vacuum steam sterilization cycle for 18 minutes at 134°C (273°F). (WHO/CDS/CSR/2000.3, "Who Infection Control Guidelines
for TSE," March 1999).
"Flash" sterilization:
Surgical centers that wish to steam sterilize patient care items for immediate use shall at a minimum follow the requirements as
outlined in ANSI/AAMI ST79:2010. Reduction of bioburden and removal of gross soil are essential steps in preparing an item for
sterilization by any method. Please follow the steps for decontamination of the instrument prior to any sterilization process
including "Flash" sterilization. The processed items must be transferred immediately, using aseptic technique, from the sterilizer to
the actual point of use. There is NO storage or shelf life of flash-sterilized items because of the probability of contamination after the
sterilizer door is opened and the items are removed. When performed correctly, flash sterilization is safe and effective for
sterilization of medical devices (AAMI ST79:2010).
Re-usable surgical instruments with moving parts require a dry cycle to keep the product functioning appropriately. "Flash"
Gravity-Steam sterilization with NO dry time is NOT recommended as a normal process of sterilization.
After steam sterilization, cool down to room temperature without additional cooling. Sudden changes in temperature
may damage the endoscope.
PRECAUTIONS
CAUTION: Do not ultrasonically clean the endoscope or use solvents other than isopropyl alcohol.
CAUTION: DO NOT exceed a temperature of 280° F (138° C).
NOTE: Video Endoscope REF 81020 or 81020N disinfectant cleaning instructions on page 12.
NOTE: For New 81025 Endoscope Sterilization: (See page 12 for illustration of New 81025 Endoscope)
1. Packaged Yellow Eye Piece Cap, Yellow Tip Cap, & Light Post Cap – Remove, NON‐AUTOCLAVABLE
2. Blue Sleeve – Keep, AUTOCLAVABLE protects scope
3. Polishing Paste – Please see instructions for removing deposits on optical surfaces.
OTHER STERILIZATION METHODS
CAUTION: Other sterilization systems have not been tested and are not recommended.
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SMARTRELEASE INSTRUCTIONS FOR USE
6
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Materials
Materials
Materials
IM-SMARTRELEASE REV E
Instrument / Accessory Only/In Sterilization Case
35 minute Full Cycle
270-275F (132-135C)
20 minutes
Double wrapping in a standard central supply wrap
Instrument / Accessory Only /or In Sterilization Case
5 minute Full Cycle
270-275F (132-135C)
20 minutes
Double wrapping in a standard central supply wrap
Instrument / Accessory Only
11 minute Full Cycle
270-275F (132-135C)
8 minutes
Unwrapped
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