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INDICATIONS
The Shiley™ range of Tracheostomy Tubes are indicated for use in
airway management in conjunction with a medical need to perform a
tracheotomy. Certain circumstances will sometimes require special features
which are described below. One product could have more than one special
feature.
INDICATIONS EVAC:
Where profuse secretions build up above the cuff or tracheal infection
needs to be minimized, the EVAC lumen versions are indicated.
WARNINGS/PRECAUTIONS
• Care should be taken to avoid damaging the ultrathin-walled cuff
during use. Do not use if cuff is damaged.
• Inflation of the cuff by "feel" alone or by using a measured amount
of air may not provide an adequate seal. (Stewart SL et al, A
comparison of endotracheal tube cuff pressures using estimation
techniques and direct intracuff measurement, AANA J. 2003;
71:443-447).
Diffusion of nitrous oxide mixture, oxygen or air may either
increase or decrease cuff volume and pressure. Nitrous oxide
diffuses through the unique material of the SealGuard tracheal
cuff at a higher rate than through a standard PVC cuff. When
using nitrous oxide mixtures, the user should frequently monitor
cuff volume and pressure and make inflation adjustments as
necessary. The use of a cuff pressure gauge is advised to verify
appropriate inflation pressure.
• Test the cuff and valve assembly prior to use. If dysfunction is
detected in any part of the inflation system, the tube should
not be used. Furthermore, the integrity of the inflation system
should be monitored both initially and periodically during use.
Uncorrected failure of the inflation system could result in patient
injury or death.
• Deflate cuff prior to repositioning the tube. Movement of the tube
with the cuff inflated could result in patient injury or damage to the
cuff, requiring a tube change. Verify the position of the tube after
each repositioning.
• Do not over inflate the cuff. Cuff pressure should routinely be
monitored and should not exceed arterial capillary perfusion
pressure. Over inflation can result in tracheal damage, rupture of
the cuff with subsequent deflation, or cuff distortion, which may
lead to airway blockage.
(General):
(Cuff related):
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