WARNINGS:
1 Prior to removal of cuffed Tracheostomy tubes, all air must
be completely removed from the cuff to prevent damage
to the trachea and stoma.
2 If the Tracheostomy tube is lubricated prior to insertion,
ensure the lubricant does not occlude the lumen of the
tube preventing ventilation of the patient.
3 Do not inflate the cuff with a measured volume of air, or
by feel of pressure from the syringe, since little resistance
should be felt during inflation.
4 During anaesthesia, nitrous oxide may diffuse into the
cuff causing an increase or decrease in cuff pressure.
5 Cuff pressures should be monitored and adjusted
routinely. Over-inflation of the cuff may result in
permanent damage to the trachea.
6 Contact with electro surgery electrodes or laser surgery
beams must be avoided because PVC will produce toxic
fumes in air or ignite in an enriched oxygen environment
(e.g. anaesthesia).
7 Never use Portex® Fenestrated Tracheostomy tubes
for manual or mechanical ventilation unless a Portex®
non fenestrated inner cannula is in place to prevent gas
leakage through the fenestrations in the Tracheostomy
tube.
8 Do not use this Tracheostomy tube in patients with
abnormal upper airway anatomy or pathology as this may
result in partial total airway obstruction.
9 If when using the Tracheostomy Change Kit the guide wire
is damaged during the procedure, it may be difficult to
continue. In these cases it may be possible to proceed
only if:
(a) the damaged section of guide wire can be advanced
into the trachea, and
(b) there is sufficient length of undamaged guide wire
remaining that the obturator does not need to pass
over the damaged section.
If the guide wire can not be salvaged or there are any
doubts about using the damaged guide wire, then a new
Tracheostomy Change Kit and guide wire should be used.
10 If a Portex® Fenestrated Tracheostomy tube is used with
a Decannulation cap, either a fenestrated inner cannula
must be used or if a non fenestrated inner cannula is
present, it should be removed, and in both cases the
tracheostomy tube cuff must be deflated. Failure to do so
may lead to partial or complete airway obstruction.
11 Caution must be exercised when using a Decannulation
cap in conjunction with a cuffed fenestrated tracheostomy
tube. The user must ensure that the cuff is completely
deflated and that a fenestrated inner cannula is used, or
that the inner cannula has been removed. Failure to do
so may result in total or partial obstruction of the airway.
Observe the patient for signs of respiratory distress and
immediately remove the Decannulation cap if required.
12 The Decannulation cap is indicated for use only with
fenestrated tracheostomy tubes.
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13 Do not lubricate the inner cannula as this may occlude
the inner cannula and prevent the inner cannula being
retained within the tracheostomy tube.
14 If it is not possible to remove the inner cannula from the
tracheostomy tube, do not try to forcibly remove. Both the
inner cannula and tracheostomy tube should be removed
together and replaced with a new tracheostomy tube and
inner cannula.
15 Where an inner cannula is used, ensure that it is both the
correct diameter and length for the tracheostomy tube in
use. Size markings are provided on the tube flange, pack
labels and additional patient labels to help identify the
correct inner cannula to use. Use only an inner cannula that
is supplied specifically for use with the Portex® Blue Line
Ultra® range.
16 Use of an inner cannula of the wrong diameter may cause
difficulties in introduction or unnecessarily restrict gas
flow. An inner cannula which is too long may protrude
excessively from the outer tube, leading to tracheal
damage or occlusion. Use of an inner cannula which is too
short may lead to build-up of secretions which could cause
infection or blockage.
17 Tracheostomy tubes must be changed regularly to suit
individual patient’s needs.
18 The use of an Inner Cannula reduces the airway size by
1.5mm (excluding size 6.0mm tracheostomy tube which
reduces the airway size by 1.0mm).
19 Do not insert a Portex® Cuffed Fenestrated Tracheostomy
Tube (100/802; 100/812; 100/832) using a percutaneous
tracheostomy or open surgical technique because in a
newly formed stoma the location of the fenestra may be
in tissue, and could result in surgical emphysema during
mechanical ventilation.
20 Portex® Purple Decannulation Cap
This cap must only be used with Portex® Blue Line Ultra®
Fenestrated Tracheostomy Tubes (100/812; 100/813).
It must not be used with Portex® Siliconised Blue Line®
Tracheostomy Tubes with the following code numbers:
100/505; 100/506; 100/512; 100/517; 100/518; 100/523;
100/526; 100/535; 100/536; 100/537; 100/538; 100/539;
109/xxx
The use of this cap with these products may prevent
the cap from being removed in a critical or emergency
situation, potentially resulting in obstruction of the
patient’s airway.
21 Do not fit an inner cannula when using a tracheostomy
tube in conjunction with a right-angled connector that
incorporates a co-axial fresh gas tube which protrudes into
the connector lumen (e.g. Norman elbow). The protruding
fresh gas tube could occlude the inner cannula, restricting
expiratory flow of gas, resulting in barotrauma/hypoxia.
22 During and after attachment of the breathing system to
the tracheostomy tube connector, avoid application of
excessive rotational or linear forces on the tube to prevent
accidental disconnection or occlusion.
Uncontrolled
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