Covidien Shiley Instrucciones De Uso página 5

en
Shiley
TM
Adult Flexible Tracheostomy Tube Cuffless
Disposable Inner Cannula
4UN65A 6.5 mm
5UN70A 7.0 mm
6UN75A 7.5 mm
7UN80A 8.0 mm
8UN85A 8.5 mm
9UN90A 9.0 mm
10UN10A 10.0 mm
Instructions for Use
POST FOR USE BY ALL TRACHEOSTOMY CARE PERSONNEL
The primary user of this instructional material is the caregiver in a clinical environment such as the
adult or critical care units of a hospital, non-critical care units of a hospital, long term care facilities
and home care.
Description
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless ("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.
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™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is intended for use in
providing tracheal access for airway management.
The Shiley™ Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula is also intended
for use with Cook® Percutaneous Dilatational Tracheotomy (PDT) procedures.
WARNINGS
• 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
combustion of the tube with harmful thermal effects and with emission of corrosive and toxic
combustion products, including hydrochloric acid (HCl).
• The tracheostomy tube, neck strap, and disposable inner cannula cannot be adequately
resterilized by the user in order to facilitate safe reuse and are therefore intended for single
patient use. Attempts to resterilize this device may result in product failure and increased risks
to the patient.
• Sterile only if the protective tray and cover are not open, damaged, or broken. Do not
resterilize. Do not store product at temperatures above 120˚F (49˚C).
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