Covidien Shiley Mode D'emploi page 2

en
Shiley
Tracheostomy Tube SealGuard
Identification of a substance that
is contained or present within the
product or packaging.
Cuff resting diameter
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.
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.
Exposure to elevated temperatures and ultraviolet light should be avoided
during storage.
As this instruction insert applies to a number of products, it is important to
read the entire insert to familiarize yourself with all the necessary steps for
correct and safe usage.
This instruction insert applies to the following Shiley™ SealGuard products:
Tracheostomy Tube Cuffed SealGuard, Adjustable Flange, Reinforced
REF 1358xx
Percutaneous Tracheostomy Tube SealGuard, Adjustable Flange,
Reinforced*
Evac Tracheostomy Tube Cuffed SealGuard
REF 3138xx
* Specially shaped tip to fit the Ciaglia Percutaneous Tracheostomy
Introducer Kit REF C-PTS-100 from Cook™* Critical Care Europe.
DESCRIPTION:
The Shiley™ range of Tracheostomy Tubes are supplied sterile with a unique
ultra thin high-volume, low-pressure cuff, unless indicated, standard 15mm
connector, obturator (depending upon product type) and tape tie. This
unique cuff material of the SealGuard products ideally gives an improved
sealing performance over historical PVC cuffed products. They are available
in an anatomical design with fixed or adjustable flanges. X-ray visualization
is assisted by the tip-to-tip radiopaque line or radiopaque flexible tube
reinforcing. Some versions also include an additional circumferential
radiopaque marker at the distal tip.
TM
REF 1378xx
Identification of a substance that is
not contained or present within the
product or packaging.
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