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KONECT RESILIA Aortic Valved Conduit, Model 11060A Accessory Care and
Sterilization Instructions for Tray Model TRAY1190
Instrucciones para la esterilización y el cuidado de accesorios del conducto aórtico
valvulado KONECT RESILIA, Modelo 11060A para la bandeja Modelo TRAY1190
Conduto aórtico valvulado KONECT RESILIA, modelo 11060A — Instruções de
cuidado e esterilização para a bandeja modelo TRAY1190
English (EN)...............................................................................................................................................................................................................................1
Español (ES)...............................................................................................................................................................................................................................3
Português do Brasil (PTBR).................................................................................................................................................................................................. 5
Symbol Legend ■ Significado de los símbolos ■ Legenda dos símbolos.......................................................................................................... 7
English
Rx only
1.0 Tray Model TRAY1190
The Tray Model TRAY1190 is intended to hold Sizers Model 1190 during sterilization and storage and allows for multiple
sterilization cycles (re-use) by steam (moist heat). The Instructions For Use supplied with KONECT RESILIA aortic valved
conduit (AVC), Model 11060A provide information on the use of this tray.
2.0 How Supplied
The tray is provided non-sterile and must be cleaned and sterilized before each use. It cannot be sterilized in its
original packaging.
3.0 Cleaning Instructions
All trays and lids 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 tray for signs of wear, such as dullness, cracking or crazing. Replace tray if any deterioration is
observed.
3.1 Instructions for Manual Cleaning:
1. Rinse the tray 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 tray in the cleaning solution and soak for a minimum of 5 minutes.
4. After the 5-minute soak time, use a soft-bristled brush and scrub the tray for a minimum of 2 minutes to remove any visible
soil.
5. Remove the tray from the cleaning solution and rinse with cold, running tap water, then in reverse osmosis/deionized
water for a minimum of 1 minute.
6. If soil is visible, repeat cleaning process.
3.2 Instructions for Automated Cleaning:
1. Rinse the tray under cold, running tap water to remove gross soil.
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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Resumen de contenidos para Edwards 11060A

  • Página 1 All trays and lids 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.
  • Página 2 2. Prepare a neutral pH cleaning solution (such as Enzol or equivalent) per the manufacturer’s recommendation. 3. Fully immerse the tray in the cleaning solution and soak for a minimum of 1 minute. Avoid contact between the sizers. 4. Load the tray with instruments as indicated by the tray markings. 5.
  • Página 3 (reutilización) con vapor (calor húmedo). En las Instrucciones de uso que se suministran con el conducto aórtico valvulado KONECT RESILIA modelo 11060A, se proporciona información sobre el uso de esta bandeja.
  • Página 4 FASE TIEMPO DE RECIRCULACIÓN TEMPERATURA TIPO DE DETERGENTE Y (MINUTOS) CONCENTRACIÓN 90–115 °C (194–239 °F) Secado 7:00 *La fase del lavado con enzimas es opcional y puede variar según el modelo de la lavadora. 4.0 Desinfección 4.1 Instrucciones para la desinfección térmica: 1.
  • Página 5 Os acessórios devem ser retirados de uso quando houver sinais de rachaduras, fissuras ou outras deteriorações evidentes. Entre em contato com o seu representante de vendas da Edwards Lifesciences para obter as peças de substituição adequadas. AVISO: verifique se a bandeja apresenta sinais de desgaste, como opacidade, rachaduras ou fissuras. Substitua a bandeja se forem observados sinais de deterioração.
  • Página 6 FASE TEMPO DE RECIRCULAÇÃO TEMPERATURA TIPO E CONCENTRAÇÃO DO (MINUTOS) DETERGENTE 90–115 °C (194–239 °F) Secagem 7:00 *A fase de lavagem enzimática é opcional e pode variar de acordo com o modelo da máquina de lavar. 4.0 Desinfecção: 4.1 Instruções para desinfecção térmica: 1.
  • Página 7 Symbol Legend ■ Significado de los símbolos ■ Legenda dos símbolos English Español Português English Español Português Reg. do Brasil Reg. do Brasil No.¹ No.¹ Catalogue Número de Número de 2493 2609 Non-sterile No estéril Não estéril Number catálogo catálogo Não use se No lo utilice 0434A...
  • Página 8 Edwards Lifesciences Services GmbH 07/21 Edisonstrasse 6 10048120001 A 85716 Unterschleissheim © Copyright 2021, Edwards Lifesciences LLC Germany All rights reserved. Telephone 949.250.2500 Web IFU 800.424.3278 Edwards Lifesciences LLC 949.250.2525 One Edwards Way Irvine, CA 92614 USA Made in USA...