Integra LifeSciences Sterilization Containers, Integra Miltex - Manual (Page 2)

caUtion: Small baskets, trays, and other types of accessories, especially
with covers and lids, should only be used with the sterilization container if the
container has been specifically designed and tested for that purpose.
caUtion: Non-absorbent tray liners (e.g., plastic/silicone- fingered organizing
mats) can cause condensate to pool. The use of these accessories within the
container has not been tested.
• Place instrument basket(s) into the prepared container bottom.
• Place lid onto the container bottom, aligning handles on bottom with
latches on lid.
• Simultaneously close both locking latches on the lid. Some downward
pressure is needed to lock the lid in place.
Processing assembly
• Insert set indicator card(s) into the holding bracket(s) on the outside of the
container. A tab at one end of the indicator card will facilitate insertion and
removal.
• Insert the plastic tamper-proof seals into the locking channel on each end.
• Secure and lock.
note: Use of internal and external indicators should be in accordance with in-
house protocol, determined by the user.
note: The process indicators validated for use with containers are Miltex
item number 3-5930-00. These indicators are for use in ethylene oxide or steam
sterilizers.
loading the sterilizer
• The container should be placed flat/level for effective sterilization
and drying.
caUtion: Containers should not be stacked when used within gravity steam
sterilizers. The containers were validated using 3 containers placed side by side
in the sterilizer.
caUtion: Do not cover filter perforated section with paper wrapped
instruments or any other objects that could obstruct the way to air flow and
sterilant flow. Permanent damage may occur to the container as a result of this
obstruction.
• The container needs to remain on the container cart, in a draft free area,
until cool enough to handle.
ProcessinG: Gravity steam
WarninG: The sterilization containers should ONLY be used at the specified
conditions described below:
Run loaded sterilizer according to the manufacturer’s instructions at:
• Temperature: 250°F (121°C)
• Exposure Time: 45 minutes
• Dry Time: 20 minutes
sHelf life
A real-time event-related shelf life study has been performed on the
containers. The conclusion of the study is that the container is capable of
storing sterilized medical devices for a maximum of 360 days as long as the
container integrity has not been compromised. If the container is not opened
or the filters perforated or contaminated, the container can be subjected to
routine storage and handling activities and sterility will be maintained.
tHe miltex container system Warranty
Miltex hereby warrants all Miltex Containers purchased directly from Miltex or
an Authorized Dealer in accordance with the following terms and conditions:
The Miltex Container is guaranteed to be free from defects in material and
workmanship when used for its intended purpose. Any Miltex Container
that proves defective in workmanship or material will either be repaired or
replaced, at Miltex discretion, without charge.
Containers not purchased from an authorized source may not be authentic or
meet Miltex quality standards.
container Gaskets Warranty
The warranty period for Miltex container gaskets is three years from the date
of purchase.
Periodic maintenance
Periodic Maintenance is suggested to ensure all parts are in good
working order.
repair or replacement
Under this Warranty, and at its discretion, Miltex will repair or replace any
parts of the product found to be defective in workmanship or material.
Miltex will determine, at its discretion, the cause and nature of any defect,
the necessity and manner of repair or replacement, and all other matters
pertaining to the conditions of the Miltex Container System.
Miltex, Inc. Returned Goods Policy applies to all returned items (refer to
details in current Surgical price list).
exclusions
This Warranty shall not apply to any conditions(s) or damage resulting from
negligence, misuse, improper handling, improper cleaning, improper opening
techniques, or unauthorized repair work including but not limited to:
• Incidents of abuse such as denting of the Miltex Container due to dropping
or other instances of mechanically applied pressure.
• Damage determined to be related to caustic or abrasive cleaning agents.
• Items modified by the customer.
• Items modified or customized by Miltex at the request of the customer.
• Damage from fire, flood and other occurrences not under the control
of Miltex
Please direct your questions concerning this Warranty to:
Miltex, Inc., 589 Davies Dr., York, PA 17402
www.miltex.com
0310/0/C/4
SURG-CONT-INST
phone 717 840-9335
toll free 866 854-8300
www.miltex.com