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Doc. No.: LC-73-0004-014 Rev. A (Dec-18)
Sterilization:
TriMed recommends the following sterilization procedures for non-sterile, instruments.
Due to variations in conditions and environments, the user has final responsibility for the implementation
and verification of procedures to achieve sterility.
1. Place clean and unused implants and screws into the designated slots of the designated caddies.
Disassemble instruments and place inside the designated caddy. Carefully close the caddy
covers.
2. Place properly cleaned and dried instruments into the designated slots inside the sterilization tray.
Disassemble instruments and place components inside sterilization tray. Where possible, hinged
instruments should be in the open position.
3. Place the implant and screw caddies into the designated locations inside the sterilization tray.
Carefully close the implant tray and clamp to seal.
4. Wrap the instrument tray with commercially available CSR wrap.
5. Place wrapped instrument tray in steam sterilizer, sterilize for 4 minutes in 132
o
C pre-vacuum
cycle with 20-minute dry time.
6. Upon cycle completion, remove the wrapped instrument tray from sterilizer and place tray on a
padded surface to prevent condensation during cooling.
7. Store the sterilized instrument tray in a clean and dry area.
General Regulatory Information
Product Labeling:
For product shipped, the following symbols may be indicated on the labels placed on the packaging:
Symbol
Symbol Description
Catalog Number
Lot Number
Date of Manufacture
Manufacturer
Single Use Only. Do Not Re-use.
Non-Sterile
Consult Instructions for Use
Caution
Caution: Federal law restricts this device to sale by or on the order of a
physician