Covidien Shiley 50XLTCD Mode D'emploi page 5

en
Shiley™ Tracheostomy Tube
This instruction insert applies to the following
Shiley products:
Tracheostomy Tube XLT Cuffed Distal with Disposable Inner Cannula
Tracheostomy Tube XLT Cuffed Proximal with Disposable Inner Cannula
Tracheostomy Tube XLT Cuffless Distal with Disposable Inner Cannula
Tracheostomy Tube XLT Cuffless Proximal with Disposable Inner Cannula
Inner Cannula XLT Disposable
Identification of a substance that
is contained or present within the
product or packaging.
Cuff resting diameter
This product contains DEHP. When used as indicated, very limited exposure to trace
amounts of DEHP may occur. There is no clear clinical evidence that this degree of
exposure increases clinical risk. However, in order to minimize risk of DEHP exposure
in children and nursing or pregnant women, this product should only be used as
directed.
This product cannot be adequately cleaned and/or sterilized by the user in order to
facilitate safe reuse, and is therefore intended for single use. Attempts to clean or
sterilize these devices may result in a bio-incompatibility, infection or product failure
risks to the patient.
Directions for Use
Indications
The devices are intended for use in providing tracheal access for airway management.
WARNINGS
• The Shiley Tracheostomy Tube XLT and obturator are single patient use
medical devices and usage should not exceed twenty-nine (29) days.
Frequent and routine changes of the tracheostomy tube and accessories are
recommended and should be evaluated by the qualified physician.
• The Shiley Inner Cannula XLT, neck strap and Shiley TTH Tracheostomy Tube
Holder are disposable medical devices and are designed for single use and should
not be cleaned or reused.
• Carefully read these instructions prior to use. These instructions are applicable
only to the Shiley Tracheostomy Tube XLT, Shiley Inner Cannula XLT.
• The products packaged in the tray inside the box are sterile unless the
package is opened or damaged. Do not resterilize. Do not expose to
temperatures above 120°F (49°C).
• The Shiley Inner Cannula XLT provided in this package can only be replaced by
a Shiley Inner Cannula XLT of the same size and catalog number.
• A Shiley Inner Cannula XLT must be in place to mechanically ventilate the patient.
Identification of a substance that is
not contained or present within the
product or packaging.
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