6
• If you are unable to insert or remove the inner cannula, contact a
physician immediately.
• Under no circumstances should more than 25 mm of mercury (Hg) air
pressure be used to inflate the cuff. Over-inflation of the cuff may cause
tracheal damage and may inhibit ventilation.
• As a further precaution for ventilator-dependent patients, cuff inflation
should be checked on a regular basis and replacement tracheostomy
tubes and inner cannula should be kept at the patient’s bedside
• Do not use the Shiley TracheoSoft XLT Extended Length Tracheostomy
Tube and Shiley TracheoSoft XLT Extended Length Disposable Inner
Cannula in procedures which will involve the use of LASER or an
electrosurgical active electrode in the immediate area of the devices.
Contact of the beam or electrode with the tracheostomy tube and inner
cannula, especially in the presence of oxygen-enriched or nitrous oxide
containing mixtures could result in the rapid combustion of the tube
with harmful thermal effects and toxic emissions.
CAUTIONS
• Precautions should be taken when discarding any of the tracheostomy tube
devices and accessories. Disposal of medical devices should be made in
accordance with applicable national regulations for biologically hazardous
waste.
• The Shiley TracheoSoft XLT Extended Length Disposable Inner Cannula, neck
strap and Shiley TTH Tracheostomy Tube Holder are designed for single use
and should not be cleaned or reused.
• Patients in the home care environment should be carefully instructed
by the Home Health Care Provider in the proper use and handling of the
tracheostomy tubes and accessories.
• To ease insertion and to guard against cuff perforation from sharp edges of
cartilage, the cuff should be tapered back. This can be accomplished by first
inflating the cuff. Then gently move the cuff away from the distal tip of the
outer cannula towards the swivel neck plate as the residual air is removed by
deflation. Do not use any sharp instruments such as forceps or hemostats that
would damage the cuff when tapering it.
• When using a water soluble lubricant, verify that the lubricant does not enter
and occlude the tube lumen, which may restrict ventilation. Petroleum-based
lubricants should not be used.
• The obturator should be cleaned (Refer to Table 4) and then stored in an
accessible location near the patient should it be needed.
• To avoid applying pressure against the patient, the neck plate may be
stabilized with your free hand during the locking procedure.
• Verify that the twist-lock connector engages securely. If parts become worn or
loose, immediately report this to the physician for prompt replacement of the
tracheostomy tube.
• This product is composed of soft materials to conform to tracheal tissue for
performance and patient comfort. Simple precautions in handling of the
Shiley TracheoSoft XLT Extended Length Tracheostomy Tube with Cuff during
insertion and while in place will facilitate proper function and minimize tears
and breaks in the cuff. Avoid pulling or manipulation of the inflation line, as
it is designed to conduct and hold air as part of the cuff inflation system. It
is recommended that the inflation line be maintained in a position allowing
for patient mobility, without placing tension on the line-to-outer cannula
