Covidien Shiley 4CN65A Mode D'emploi page 4

en
TM
Shiley
Adult Flexible Tracheostomy Tube with
TaperGuard Cuff
TM
Disposable Inner Cannula
4CN65A 6.5 mm
5CN70A 7.0 mm
6CN75A 7.5 mm
7CN80A 8.0 mm
8CN85A 8.5 mm
9CN90A 9.0 mm
10CN10A 10.0 mm
Instructions for Use
POST FOR USE BY ALL TRACHEOSTOMY CARE PERSONNEL
Description
The Shiley™ Tracheostomy Tube with TaperGuard™ Cuff ("tracheostomy tube") is a dual cannula
tracheostomy tube with a disposable inner cannula. It contains an integrated 15 mm connector for
use with standard ventilation and anesthesia equipment.
The tracheostomy tube has a radiopaque, bio compatible outer cannula constructed of polyvinyl
chloride. A pliable neck plate allows conformity to individual neck anatomies and contains two
suture holes. The tapered tracheostomy tube tip is compatible with percutaneous insertion. The
smooth, rounded tip obturator facilitates insertion. The disposable inner cannula is translucent for
easy inspection and allows for airway maintenance.
The tracheostomy tube has a taper-shaped, low-pressure cuff to provide an ef fective air and fluid seal
and minimize tracheal wall damage. The cuff inflation line has a luer valve with an integral pilot balloon.
This tracheostomy tube can be used with or without the disposable inner cannula included in the
package (and also available separately; reference 10006780 for part numbers). However, use of the
inner cannula is recommended.
Indications for Use
The Shiley™ Tracheostomy Tube with TaperGuard™ Cuff is intended to provide tracheal access for
airway management.
The Shiley™ Tracheostomy Tube with TaperGuard™ Cuff is also intended for use with Percutaneous
Dilatational Tracheotomy (PDT) procedures.
warnIngs
• Under no circumstances should more than 25 cm of H
Over-inflation of the cuff may cause tracheal damage and may inhibit ventilation. Consult with
the attending physician.
• Test each tube's cuff, pilot balloon, and valve by inflation prior to use. If dysfunction is detected
in any part of the inflation system, the tube should not be used.
• Inflation volumes listed on page 2 are for test purposes only. Consult the physician or home
health care provider for the appropriate inflation volume/pressure when the tube is positioned
within the trachea.
• When using a laser or electrosurgical device in conjunction with this or other tracheal tubes,
care must be taken to avoid contact with the tube. Such contact, especially in the presence of
oxygen-enriched mixtures or nitrous oxide containing mixtures, could result in rapid combus-
tion of the tube with harmful thermal effects and with emission of corrosive and toxic combus-
tion products, including hydrochloric acid (HCl).
• Diffusion of nitrous oxide, oxygen, or air can alter cuff volume and pressure.
• The tracheostomy tube and neck strap cannot be adequately resterilized by the user in order
to facilitate safe reuse and are therefore intended for single patient use. Attempts to resterilize
Identification of a substance
that is contained or present
within the product or packaging.
Identification of a substance
that is not contained or present
within the product or packaging.
O air pressure be used to inflate the cuff.
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