Cleaning and Sterilization Instructions
for Plastic Trays
Instructions Recommended For Use With
ANKLYOS and XiVE Surgical Kit Plastic Trays
Filled trays must not be cleaned or disinfected.
When using the tray collect used instruments separately
and do not replace them in the tray. This will prevent
greater contamination and make it unnecessary to
clean and disinfect the filled tray.
Clean and disinfect the used instruments, then place
them in the tray and sterilize the instrument tray with all
the instruments in their places.
The initial disinfection cannot replace the subsequent
disinfection step required after cleaning.
Use only neutral cleaning agents and disinfectants
without chlorine, ammonia, phenol, aldehydes that are
suitable for cleaning and disinfecting plastic
instruments. Disinfectants must conform to the
applicable national regulations for disinfectants (such
as FDA approval, CE mark, DGHM/VAH listing). If
disinfectants containing aldehyde are used, they may
fix blood or protein. If ultrasonic baths are used,
non-foaming cleaning agents and disinfectants must be
Use only water with a bioburden ≤ 10 CFU/ml and an
endotoxin burden ≤ 0.25 IU/ml (e.g. water for
cleaning or freshly prepared purified or ultrapurified
water in accordance with the pharmacopoeia).
The internal padded insert is for protection during
shipping only and must be removed before using the
tray for the first time. The padded insert must never be
All trays must be cleaned, disinfected and sterilized
before using them for the first time and then after every
use and every time they are contaminated. If greater
contamination can be avoided (used instruments not
returned to tray, no visible contamination on the tray),
it is not necessary to clean and disinfect the trays. In
this case the used instruments must be cleaned and
disinfected separately and the loaded trays sterilized.
However, thorough cleaning and disinfection is
absolutely essential for effective sterilization.
Please also follow the relevant instructions in the
manual on sterilization and instrument care.
4. Rinsing and drying
Large or visible impurities must be removed from the trays
immediately after use (no more than two hours later).
After disinfection rinse all parts thoroughly with water as
specified by the disinfectant manufacturer. Move the parts
back and forth.
Remove all instruments from the trays (separate cleaning
and disinfection as directed by the manual for sterilization
and instrument care).
Use running water (rinse thoroughly for at least one minute)
or a disinfectant solution (rinse thoroughly three times). Use
only a soft brush or a clean soft cloth, which is sued for
this purpose only, for manual removal of impurities, never
metal brushes or steel wool.
Dry all parts with lint-free disposable cloths (do not use
recycled cloths). Use oil-free compressed air to dry holes.
5. Maintenance and assembly
Reassemble the trays. Do not use instrument oil or
Disassemble the trays completely.
6. Preparation for sterilization
Immerse the disassembled trays in a freshly prepared
cleaning bath of the specified concentration for the period
specified by the manufacturer.
Clean the surfaces with a soft brush until there is no visible
contamination. Clean the holes separately with a fine
brush. Clean the bottom of the modules thoroughly and
also the parts between the hard and soft plastic parts.
After cleaning rinse all parts thoroughly with water at least
three times. Move the parts back and forth.
Place the separately cleaned and disinfected instruments
back into the trays. Please pack the trays in disposable
sterilization packs (single or double packs) and/or sterilization containers that conform to the following
DIN EN ISO/ANSI AAMI ISO 11607
Suitable for steam sterilization (temperatures up to
at least 137 °C (279 °F), adequate steam permeability)
Adequate protection of trays and sterilization packages
from mechanical damage
Regular maintenance in accordance with the
manufacturer‘s specifications (sterilization containers)
Immerse the disassembled tray into a freshly prepared
disinfectant bath of the specified concentration for the
period specified by the manufacturer.
DENTSPLY Tulsa Dental Specialties
DENTSPLY International, Inc.
5100 E. Skelly Drive, Suite 300
Tulsa, OK 74135
See instructions for sterilization and instrument care,
Products Manufactured By
© 2008 DENTSPLY International, Inc. IMTRAYIS 09/08