Tracoe Twist 301 Instructions D'utilisation page 12

quantities of condensate are inadvertently aspirated into the in-
flation line, it is no longer possible to measure and adjust the cuff
pressure correctly and the tube needs to be replaced. Before
removing the tube, remove as much air or water from the cuff as
possible using a syringe.
• When using together with other medical devices, the
respective instructions for use must be observed. If in doubt,
contact the manufacturer.
6. Warnings
• Do not use if the sterile packaging is not intact.
• Never use fenestrated inner cannulas for ventilation.
• Use the occlusion cap only with fenestrated tubes (outer +
inner cannula) and an unblocked cuff.
• Do not use a speaking valve during sleep.
• When using laser or electrosurgical treatment equipment,
ensure that the tracheostomy tube is at a safe distance. There is
a risk of fire and toxic gases and the tube may get damaged.
• Select the correct tube to ensure that the fenestration (if
applicable) is positioned at sufficient distance from the stoma ca-
nal. Failure to do so exposes ventilated patients to the risk of em-
physema. Granulation tissue may also form or airway resistance
may increase if speaking valves or occlusion caps are used.
• If a fenestrated tube is used, there is a risk of increased
formation of granulation tissue.
• The cuff pressure can change, for example due to alti-
tude changes (e.g. in an aircraft), or if laughing gas is used as
an anaesthetic or during the connection and disconnection of a
hand-held manometer.
• Excessive cuff pressure poses a risk of permanent dam-
age to the trachea.
• Excessive cuff pressure may give rise to cuff hernias.
• Insufficient cuff pressure poses a risk of aspiration.
• Ensure that the correct Luer connectors are used
(e.g. 2a + 9).
• During insertion and removal of the tube, irritation, need to
cough or bleeding may occur.
7. Adverse Reactions
Pressure points, necrosis, skin irritation, granulation tissue, need
to cough, difficulty swallowing, and bleeding.
EN
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