Owner manual

Sterilization
1. Wrap cassee in FDA-cleared sterilization wrap; seal wrap with autoclave tape.
2. Date and code cassee on autoclave tape or label on outside of wrapped cassee.
3. Place wrapped cassee into sterilization unit and follow sterilizer’s recommended sterilization
procedures and an approved National/International Standard.
Integra
™
Miltex® cassees have been tested with no adverse effects under the following
sterilization parameters:
Gravity Steam: Pre-Vacuum Steam:
Temperature: 250ºF (121ºC) Temperature: 270° F (132°C)
Exposure Time: 30 minutes Exposure Time: 4 minutes
Dry Time: 20 minutes Dry Time: 20 minutes
4. Aer sterilization, remove cassee from sterilization unit and place in a storage location.
Cassees wrapped in FDA-cleared sterilization wrap maintain sterility of enclosed instruments
for 30 days as long as sterile barrier is not compromised.
Maintenance Of Cassee
• Integra
™
Miltex® cassees have been validated to withstand up to 50 sterilization cycles with no
evidence of deterioration.
• Forbestandlengthyservicelife,instrumentcasseesshouldbeallowedtoproperlydrybefore
the sterilization procedure.
• UseIntegra
™
Miltex® Instrument Stain Remover to remove water marks or stains if they appear on
cassee.
How Supplied
Integra
™
Miltex® Cassees are supplied one per package in a variety of configurations.
Symbols Used On Labeling
Manufacturer
Catalog number
Lot number
CAUTION:Seewarningsorprecautions
Consult instructions for use
CAUTION:Federal(USA)lawrestrictsthisdevicetosalebyoron
the order of a dentist or physician.
Integra
™
Miltex
®
Instrument Cassee
Directions For Use
Directions For Use
Integra
™
Miltex® Instrument Cassees
Device Description
Integra
™
Miltex® Cassees are sterilization cassees made of surgical-grade
passivated stainless steel to provide protection, storage and organization for
all types of instruments. Integra
™
Miltex® Cassees may be used in dental,
surgical or veterinary procedures. Cassees are available in a variety of
configurations and are designed to fit standard autoclaves.
Indications For Use
Integra™ Miltex® Cassees are general dental/surgical instrument cassees
indicated to hold instruments and accessories in place during storage and
the sterilization cycle. Suitable for gravity steam and pre-vacuum steam, the
cassees are intended to be used in conjunction with sterilization wrap in
order to maintain sterility.
Contraindications
• None
Warnings
• Donotstackoroverllinstrumentsincassee;ensurethateach
instrument is correctly placed into slots provided.
• Closecasseelidtoavoidinjurycausedbyinstrumentsprotrudingfrom
cassee.
• Donotstackcasseesinsterilizationunit.
• Donotuseanyunusedinstrumentsinthecasseeoncesoiledinstruments
have been placed back into the cassee.
Precautions
• WrapinstrumentcasseeonlywithlegallymarketedFDA-cleared
sterilization wrap.
• Useofnonabsorbenttrayliners,suchasplastic/silicone-ngered
organizing mats, can cause condensate to pool inside cassee.
• Smallbaskets,trays,andothertypesofaccessories,especiallythosewith
covers or lids, should be used with cassees only if cassees have been
specifically designed and tested for such purpose.
• Complexinstrumentsshouldbepreparedandsterilizedaccordingto
instrument manufacturer’s instructions.
• Foreectivesterilizationanddrying,theweightofthewrappedsurgical
cassee and its contents should not exceed 4.4 lbs per the validated
sterilization study.
Directions For Use
Cassee Cleaning
1. Cassees should be cleaned with an instrument brush and surfactant or
detergent and water to remove visible debris from all crevices prior to use.
2. Cassees may be cleaned in an ultrasonic cleaner with an enzymatic
solution, such as Integra
™
Miltex® EZ-Zyme All Purpose Enzyme Cleaner.
3. Submerge cassee fully into ultrasonic unit and place lid on unit.
4. Process single layer cassees for 15 minutes and double layer cassees for
30 minutes in ultrasonic unit.
5. Following ultrasonic cleaning procedure, remove cassees and thoroughly
rinse with warm water to remove cleaning solution; allow cassee to dry
before placing instruments in cassees for processing.
Manual Cleaning - Instruments
1.Openinstrumentcasseebypressingpushbuontoreleaselid.Foldlid
under cassee or lay lid flat on a table or work station.
2. Remove visible debris from each reusable instrument by scrubbing
instrument manually with an instrument brush and surfactant or detergent
and water.
3. Rinse with water to remove chemical or detergent residue.
4. Dry instruments and place them into cassee. Hand instruments fit into
grooves on racks inside cassee; additional instruments can be placed in
accessory area of cassee.
5. Close cassee lid tightly aer placing instruments in cassee.
Integra York PA, Inc.
n
589 Davies Drive, York, PA 17402
866-854-8300USA
n
717-840-2763outsideUSA
717-840-9347 fax
integralife.com/integra-miltex
Integra and the Integra logo are trademarks of, and Miltex is a registered trademark of, Integra LifeSciences Corporation or its
subsidiaries.©2011IntegraLifeSciencesCorporation.Allrightsreserved.PrintedintheUSA.10KL76-DENTCASSIFURev210/11
ENGLISH