Edwards KONECT RESILIA 11060A Manual De Instrucciones

KONECT RESILIA Aortic Valved Conduit, Model 11060A Accessory Care and
Sterilization Instructions for Sizer Model 1190
Instrucciones para la esterilización y el cuidado de accesorios del medidor
modelo 1190 del conducto aórtico valvulado KONECT RESILIA modelo 11060A
Conduto aórtico valvulado KONECT RESILIA, modelo 11060A — Instruções de
cuidado e esterilização para o medidor modelo 1190
English (EN)...............................................................................................................................................................................................................................1
Español (ES)...............................................................................................................................................................................................................................3
Português do Brasil (PTBR).................................................................................................................................................................................................. 5
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English
1.0 Sizer Model 1190
The Sizer Model 1190 is intended to facilitate the selection of the appropriate size of KONECT RESILIA aortic valved conduit
(AVC), Model 11060A. Sizers are available in sizes 19, 21, 23, 25, 27 and 29 mm. Sizer Model 1190 allows for direct observation
of KONECT AVC fit within the annulus after the native leaflets have been removed or prior prosthetic valve is removed.
The Instructions For Use supplied with KONECT RESILIA AVC provide information on the use of these sizers.
2.0 How Supplied
The sizers are packaged separately, provided non-sterile and must be cleaned and sterilized before each use. They
cannot be sterilized in their original packaging.
3.0 Cleaning Instructions
All sizers must be cleaned and sterilized prior to each use in accordance with appropriate hospital procedures and the
following recommended instructions and parameters. Accessories should be retired from use when signs of cracking, crazing,
or other deterioration is evident. Contact your Edwards Lifesciences sales representative to obtain appropriate replacements.
CAUTION: Examine sizers for signs of wear, such as dullness, cracking or crazing. Replace sizer if any deterioration is
observed.
WARNING: Fragments of the sizers cannot be located by means of an external imaging device.
3.1 Instructions for Manual Cleaning
1. Rinse the sizers under cold, running tap water to remove gross soil.
2. Prepare a neutral pH cleaning solution (such as Enzol or equivalent) per the manufacturer's recommendation.
3. Fully immerse the sizers in the cleaning solution and soak for a minimum of 5 minutes. Avoid contact between the sizers.
4. After the 5 minute soak time, use a soft-bristled brush and scrub the sizers for a minimum of 2 minutes to remove any
visible soil.
5. Remove the sizers from the cleaning solution and rinse with cold, running tap water, then in reverse osmosis/deionized
water for a minimum of 1 minute.
Edwards, Edwards Lifesciences, the stylized E logo, KONECT, KONECT RESILIA, and RESILIA are trademarks of
Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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