Edwards 1140M Instructions D'entretien

Care and Sterilization Instructions for Model 1140M Flex Handle, Model 1173B/R
Sizers, and Model SET1173 Tray
Instructions d'entretien et de stérilisation de la poignée flexible, modèle 1140M,
des calibreurs, modèles 1173B/R et du plateau, modèle SET1173
English (EN)...............................................................................................................................................................................................................................1
Français (FR)..............................................................................................................................................................................................................................4
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English
1.0 Accessories
These instructions apply to the following accessories: model 1140M handle, model 1173B/R sizers, and model SET1173 tray
and lid, for use with MITRIS RESILIA mitral valve, model 11400M.
The Instructions For Use supplied with MITRIS RESILIA mitral valve, model 11400M provide information on the use of these
accessories.
2.0 How Supplied
The accessories are packaged separately, provided non-sterile and must be cleaned, disinfected and sterilized before
each use. They cannot be sterilized in their original packaging.
3.0 Cleaning Instructions
The accessories must be cleaned, disinfected, and sterilized prior to each use in accordance with appropriate hospital
procedures and the following recommended instructions and parameters.
The 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 the accessories for signs of wear, such as dullness, cracking or crazing. Replace the handled if any
deterioration is observed.
WARNING: Fragments of handles and sizers are not radiopaque and cannot be located by means of an external
imaging device.
3.1 Instructions for Manual Cleaning:
Step Procedure
1
Rinse the handle 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 (1 oz per 1 gallon (30 ml per 3.8 liters) of warm tap water).
3
Fully immerse the handle in the cleaning solution and soak for a minimum of 5 minutes. Avoid contact
between the accessories.
Edwards, Edwards Lifesciences, the stylized E logo, MITRIS, MITRIS RESILIA, and RESILIA are trademarks of
Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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