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dures, in order to provide immediate ventilation through alternative airways, (e.g. trans laryngeal
intubation, laryngeal mask).
•
Optimum oxygen levels must be established in the patient before cannulation or re-cannulation.
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It is strongly recommended that a ready-to-use spare device is kept at the patient's bed-
EN
side. Store the spare device under clean and dry conditions.
•
The product should be inspected for integrity and function prior to use/insertion. Verify that
the tube is free of obstruction and the cuff material is not brittle or torn and can be inflated/deflated,
absence of kinks, tears or cuts, stable connection between the tube and the neck flange, etc. If
the product is damaged, it should be replaced with a new product
•
The sterile packaging should be inspected for damage prior to opening. If the packaging is
damaged or has been unintentionally opened, the device should not be used.
•
While in placement, use or removal of the tracheostomy tube do not use excessive forces.
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Do not use unnecessary force on the tracheostomy tube when connecting to or discon-
necting from external devices. This may result in damage of the tracheostomy tube and/or dis-
placement / decannulation.
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Always hold the tracheostomy tube at the base of the 15 mm connector when connecting
to or disconnecting from external devices.
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Do not move the adjustable neck flange along the tube axis without unlocking it.
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Lubricating gel might inhibit the locking mechanism of the adjustable neck flange. Ensure
that the lubricating gel is applied only on the areas described in chapter "Preparation".
•
The cuff pressure can change if nitrous oxide (laughing gas) is used as an anesthetic.
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All parts of the cuff inflation system must be free from strain and kinking during measure-
ment of the cuff pressure, otherwise the manometer may show incorrect pressure values.
•
Ensure that all allowed objects (e.g. hand-held manometer) used to inflate the cuff are clean
(free of dust, visible particles, and contaminants). Any obstruction of the cuff filling system may
result in deflation of the cuff which will reduce efficiency of ventilation or protection from aspiration.
•
To avoid damage to the cuff and improve ease of insertion, always ensure that the cuff is
deflated prior to insertion with the deflated cuff towards the neck flange.
•
Do not move the neck flange with excessive force against the stop near the 15 mm con-
nector. Otherwise the cuff inflation line may be damaged.
•
When a manometer and/or a connection tube is attached to the filling line of an inflated cuff,
there will always be pressure compensation between cuff and connected device. This will result in a
slight pressure loss in the cuff. If necessary, re-adjust the pressure until it is within the optimal range.
•
Water inside the Cuff: All HVLP cuffs have a certain degree of permeability to water vapor.
Therefore, condensed water vapor may accumulate inside the cuff. If larger quantities of water
inadvertently enter the inflation line, it may lead to improper cuff pressure measurement, cuff pres-
sure adjustment, and cuff deflation. In this case, the tracheostomy tube must be replaced.
•
During subglottic suctioning, ensure that negative pressure is not excessive and not applied
for an extended period in order to avoid drying out of the subglottic area. Intermittent suction is
recommended. Closing the cap of the suction line port after suctioning will reduce the drying-out
effect. The suction line may be blocked due to accumulated and/or dried secretions inside the
suction line or during suctioning of excessive fluid. If the suction line becomes blocked, follow
instruction in chapter "Subglottic Suction".
•
Improper storage conditions may result in product or sterile barrier damage.
6.
Warnings
•
Do not use this product if the sterile packaging has been compromised/damaged, e.g.
open edges, holes in packaging etc.
•
Reprocessing (including re-sterilisation) is not allowed, this may influence the material and
function of the product. The products are single use only.
•
Modifications of TRACOE products are not allowed. TRACOE will not be responsible for
modified products.
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