Integra Miltex Instrucciones De Uso

Integra Miltex
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®
Instrument Cassette
Directions For Use
Directions For Use
Integra Miltex® Instrument Cassettes
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Device Description
Integra Miltex® Cassettes are sterilization cassettes made of surgical-grade
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passivated stainless steel to provide protection, storage and organization for
all types of instruments. Integra ™ Miltex® Cassettes may be used in dental,
surgical or veterinary procedures. Cassettes are available in a variety of
configurations and are designed to fit standard autoclaves.
Indications For Use
Integra™ Miltex® Cassettes are general dental/surgical instrument cassettes
indicated to hold instruments and accessories in place during storage and
the sterilization cycle. Suitable for gravity steam and pre-vacuum steam, the
cassettes are intended to be used in conjunction with sterilization wrap in
order to maintain sterility.
Contraindications
• None
Warnings
• Do not stack or overfill instruments in cassette; ensure that each
instrument is correctly placed into slots provided.
• Close cassette lid to avoid injury caused by instruments protruding from
cassette.
• Do not stack cassettes in sterilization unit.
• Do not use any unused instruments in the cassette once soiled instruments
have been placed back into the cassette.
Precautions
• Wrap instrument cassette only with legally marketed FDA-cleared
sterilization wrap.
• Use of nonabsorbent tray liners, such as plastic/silicone-fingered
organizing mats, can cause condensate to pool inside cassette.
• Small baskets, trays, and other types of accessories, especially those with
covers or lids, should be used with cassettes only if cassettes have been
specifically designed and tested for such purpose.
• Complex instruments should be prepared and sterilized according to
instrument manufacturer's instructions.
• For effective sterilization and drying, the weight of the wrapped surgical
cassette and its contents should not exceed 4.4 lbs per the validated
sterilization study.
Directions For Use
Cassette Cleaning
1. Cassettes should be cleaned with an instrument brush and surfactant or
detergent and water to remove visible debris from all crevices prior to use.
2. Cassettes may be cleaned in an ultrasonic cleaner with an enzymatic
solution, such as Integra Miltex® EZ-Zyme All Purpose Enzyme Cleaner.
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3. Submerge cassette fully into ultrasonic unit and place lid on unit.
4. Process single layer cassettes for 15 minutes and double layer cassettes for
30 minutes in ultrasonic unit.
5. Following ultrasonic cleaning procedure, remove cassettes and thoroughly
rinse with warm water to remove cleaning solution; allow cassette to dry
before placing instruments in cassettes for processing.
Manual Cleaning - Instruments
1. Open instrument cassette by pressing push button to release lid. Fold lid
under cassette 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 cassette. Hand instruments fit into
grooves on racks inside cassette; additional instruments can be placed in
accessory area of cassette.
5. Close cassette lid tightly after placing instruments in cassette.
Sterilization
1. Wrap cassette in FDA-cleared sterilization wrap; seal wrap with autoclave tape.
2. Date and code cassette on autoclave tape or label on outside of wrapped cassette.
3. Place wrapped cassette into sterilization unit and follow sterilizer's recommended sterilization
procedures and an approved National/International Standard.
Integra ™ Miltex® cassettes have been tested with no adverse effects under the following
sterilization parameters:
Gravity Steam:
Temperature: 250ºF (121ºC)
Exposure Time: 30 minutes
Dry Time: 20 minutes
4. After sterilization, remove cassette from sterilization unit and place in a storage location.
Cassettes wrapped in FDA-cleared sterilization wrap maintain sterility of enclosed instruments
for 30 days as long as sterile barrier is not compromised.
Maintenance Of Cassette
• Integra ™ Miltex® cassettes have been validated to withstand up to 50 sterilization cycles with no
evidence of deterioration.
• For best and lengthy service life, instrument cassettes 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
cassette.
How Supplied
Integra Miltex® Cassettes are supplied one per package in a variety of configurations.
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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 York PA, Inc. 589 Davies Drive, York, PA 17402
n
866-854-8300 USA 717-840-2763 outside USA
n
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
Pre-Vacuum Steam:
Temperature: 270° F (132°C)
Exposure Time: 4 minutes
Dry Time: 20 minutes