Le Maitre Trivex 7205683 Mode D'emploi page 2

TRIVEX® Sterilization Tray
(Model Number 7205683)
Instructions for Use - English
Instructions for Use/Intended use
The LeMaitre TRIVEX® Sterilization Tray is intended for the protection, organization and the delivery to the surgical
eld of surgical instruments and/or other medical devices. The TRIVEX Sterilization Tray is not designed to maintain
sterility by itself. It is designed to facilitate the sterilization process when used in conjunction with a wrapping
material (FDA cleared sterilization wrap) or a speci ed ltered sterilization container system. Wrapping materials
and sterilization containers are designed to allow air removal, steam penetration/evacuation (drying) and maintain
the sterility of the internal components.
Recommendations for Care, Cleaning and Sterilization Tray
Both physical and chemical (detergent) processes may be necessary to clean soiled items. Chemical (detergent)
cleaners alone cannot remove all soil and debris; therefore, a careful manual cleaning of each item with a soft
sponge or cloth is essential for maximum decontamination. For di cult access areas, a clean soft bristled brush is
recommended. Once the items have been cleaned, they should be thoroughly rinsed with clean water to remove
any detergent or chemical residue before sterilization. LeMaitre Vascular recommends the use of a mild enzymatic
detergent with a near neutral pH. Do not use solvents, abrasive cleaners, metal brushes or abrasive pads. Tray may be
placed in mechanical cleaning equipment. Always inspect for cleanliness or damage before use. Make sure all latches
and handles are secure and in working order. Do not overload trays. Balance contents uniformly within the container
and arrange to allow steam to come in contact with all objects in the container. LeMaitre Vascular recommends that
the tray be processed according to the sterilization wrap or ltered container manufacturers instructions prior to
sterilization to maintain sterility of internal components/items and for proper aseptic presentation to the surgical
eld.
For steam autoclaves, the manufacturer has veri ed product performance in the following cycles. Testing was
done with common surgical appliances such as reamers, drills, hammers, rasps, drivers, chisels, awls, handpieces,
rongeurs, blades and bits, including short lumened devices.
Complex instruments may require disassembly and extended sterilization times. Always follow instrument
manufacturer instructions if their sterilization or drying recommendations exceed these guidelines.
1. Prevacuum Sterilizer
Wrapped cases, trays and instruments, or cases, trays and instruments should be exposed to 132° C to 135° C (270° F
to 275° F) for at least four minutes. Dry for 20 to 40 minutes.
2. Gravity Displacement Sterilizer
Wrapped trays and instruments should be exposed to 132° C to 135° C (270° F to 275° F) for at least 30 minutes, or
121° C to 123° C (250° F to 254° F) for at least 55 minutes. Dry for 20 to 50 minutes.
Variables that may a ect drying times include: loading density of the case/tray, instrument con guration, total
contents of the sterilizer, steam quality, equipment maintenance and others.
3. Ethylene Oxide Sterilization
The TRIVEX Sterilization Tray has been validated for Ethylene Oxide Sterilization using 10/90 cycle
(10%EO/90%HCFC). A minimum two hour exposure cycle at 52° C to 57° C (125° F to 135º F) is required. Validation
testing was done with common surgical appliances, scopes and scope accessories, including stainless steel lumened
devices up to 8 1/2 inches. Complex instruments may require disassembly and extended sterilization times. Always
follow instrument manufacturer instructions if their sterilization recommendations exceed these guidelines. Always
follow instrument manufacturer instructions regarding use in Ethylene Oxide systems. Trays have been shown to be
within acceptable residual ranges after degassing for 12 hours.
4. Filtered Sterilization Container Systems
The TRIVEX Sterilziation Tray has been validated for placement inside Ultra Container, Genesis and Aesculap ltered
sterilization container systems and exposed to 132º C to 135º C (270º F to 275º F) for at least four minutes for
prevacuum sterilizers only. Systems have not been validated for use in ltered sterilization containers in gravity
displacement sterilizers and should not be used in such a system.
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