TRAY LINER IFU

PRODUCT DESCRIPTION

PRIMED single use tray liners are intended to line the bottom of sterilization trays to absorb excessive moisture.
They may also be used to cushion medical devices and protect sharp instruments. The product size is 20” x 25”.

INDICATIONS FOR USE

PRIMED tray liners are validated for use in pre-vacuum steam and EO sterilization systems:

  • Pre-vacuum steam at 270°F/132°C for 4 minutes.
  • 100% Ethylene oxide (EO) concentration of 725-735 mg/L at 131/55°C and 40-80% humidity for 60 minutes.
WARNINGS
  • Not suitable for use in hydrogen peroxide and gas plasma sterilization systems.
INSTRUCTIONS FOR USE

The PRIMED tray liners should be used in accordance with the preparation, wrapping and sterilization chamber loading
recommendations from the following standards:

  • ANSI/AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
  • ANSI/AAMI ST41: Ethylene Oxide Sterilization in Health Care Facilities
  • AORN Standards, Recommended Practices, and Guidelines
  • CAN/CSA Z314
  • ISO 11607-1
DISPOSAL
  • PRIMED tray liners are not intended for re-use. PRIMED Medical Products is not responsible for any consequences that may come from re-use of PRIMED tray liner after it has already been processed.
  • Facilities should follow the appropriate internal and legal protocols to dispose of soiled liners after wrapped packages are opened.

DISCLAIMER: The information supplied in this document is for guidance only and should not be construed as a warranty. All implied warranties are expressly disclaimed, including without
limitation any warranty of merchantability of fitness for use. All users of the material are responsible for ensuring that it is suitable for their needs, environment and end use. All data is
subject to change as PRIMED deems appropriate.