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Tracoe twist 301-P Instructions D'utilisation page 11

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4.
Contraindications
4.1
Absolute Contraindications
Not suitable for emergency tracheostomy/cricotomy.
Existing infections in the tracheostomy area,
Existing malignancy in the tracheostomy area,
Unstable fracture of the cervical spine,
Unclear identification of anatomical marker points, and
unsuitable anatomical conditions.
Do not use the occlusion cap (10)/speaking valve in laryn-
gectomised patients (patients without a larynx) – risk of suffocation!
4.2
Relative Contraindications
Relative contraindications are cases where the risks and benefits
of the procedure must be carefully evaluated:
An enlarged thyroid,
Previous surgical intervention in the neck and throat area
(e.g. thyroidectomy),
Strong tendency to bleeding, e.g. during treatment with
anticoagulants,
Unusually deep trachea, e.g. in obese patients, where an
extra-long tube may be required,
Paediatric use.
5.
General Precautions
For the first percutaneous dilation tracheostomy, always
keep an identical set at hand as a replacement.
You are strongly advised to keep a ready-to-use spare
tube and several spare inner cannulas at the patient's bedside.
Store in a clean and dry state.
Check the tube for integrity and correct function prior to
use/insertion. Check, for example, for the absence of obstruction,
cuff seal, correct and stable fit of the inner cannula inside the
outer cannula, absence of kinks, stable connection between the
tube and the neck flange, etc. The cuff material must not be brittle.
If the product is damaged, replace with a new product.
Do not use force on the tracheostomy tube, as this may
damage or break it. If the connections at the 15 mm connector
are tightly fixed, always use a disconnect wedge approved for
tracheostomy tubes.
Keep the 15 mm connector (3a) clean and dry.
When changing the inner cannula, always ensure that the
inflation line (2a) of the cuff is not positioned between the inner
and outer cannulas, as it may get trapped and damaged.
When repositioning the patient in bed, ensure that the pa-
tient does not lie on the pilot balloon (2a), as this would greatly
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