Fahl SPIRAFLEX Instrucciones De Uso página 17

Please follow the instructions provided with the tube holder carefully when attaching and removing it
from your tracheostomy tube.
Ensure that the Fahl tracheostomy tube is placed in the tracheostoma without tension and the position
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is not changed when fastening the tube holder.
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2. Connectors and adapters
Connectors and adapters are used to connect compatible tube accessories.
The options available to a patient depend on the clinical condition, such as status post laryngectomy
or tracheostomy.
A 15 mm standard connector enables secure connection to required accessories.
3. Cannula tube
The cannula tube borders directly on the neck flange and directs the airflow into the trachea.
The neck flange is attached to the cannula tube and can be variably affixed to the tube by means of
a screw.
3.1. Low-pressure cuff
In the product versions with low-pressure cuff, the very thin-walled, high-volume low-pressure cuff
adapts well to the trachea and ensures reliable sealing if inflated correctly. The low-pressure cuff
can be inflated like a balloon. The small pilot balloon on the inflation tube indicates whether the
tracheostomy tube is in sealed (inflated) or non-sealed condition.
The low pressure cuff is inflated via a pilot line with one-way valve and pilot balloon.
3.1.1 Leakproofness test of the cannula and the low-pressure cuff (if present)
The cannula and the low pressure cuff must be tested for leakages directly before and after
every insertion and thereafter at regular intervals. For this purpose, inflate the low-pressure
cuff to 15 to 18 mm Hg (1 mm Hg corresponds to 1.35951 cm H2O) and then observe
whether a spontaneous drop in pressure occurs (recommended for inflating and testing:
Cuff pressure gauge control inflator, REF 19500). There should be no substantial drop in pressure
during the observation period. This leakproofness test must also be performed prior to every renewed
insertion (e.g. after cleaning the tracheostomy tube) (see picture 7c).
The following are possible signs indicating leakages in the cuff (balloon):
- Externally visible damage to the balloon (holes, fissures etc.)
-Audible and/or tactile perception of air escaping from the balloon
- Water in inlet tubes of the tracheostomy tube (after cleaning!)
- Water in the cuff (after cleaning!)
- Water in the pilot balloon (after cleaning!)
- No cough stimulus when pressure is applied to the pilot balloon
CAUTION!
When testing the balloon or when inserting, removing or cleaning the tracheostomy tube, never
under any circumstances use sharp or pointed objects, such as for instance forceps or clamps,
since these can damage or even destroy the balloon. Should one of the above-named signs of
leakage be detectable, the tracheostomy tube must under no circumstances be used any more
since it is no longer functioning properly!
3.2 Insertion aid
Before inserting the tracheostomy tube, please check whether the insertion aid can easily be removed
from the tube! After checking the insertion aid for ease of movement, reinsert the insertion aid into the
tracheostomy tube for insertion of the tube.
The insertion aid serves to stabilise the tracheostomy tube during insertion into the tracheostoma.
The insertion aid can also be used to absorb secretion fluids and convey these to the secretion
container. At the end of the insertion aid, there is a tube connector/Fingertip, by means of which the
suction tube of the suction device is connected to the insertion aid (see picture 12)
The Fingertip/tube connector can be used to control the suction power of the suction device.
Please read the corresponding instructions for use of the suction device carefully.
CAUTION!
Make sure to read all accompanying product information, instructions for use, indications and
contraindications. Discuss use of the product with your doctor/physician before first use.
Insertion aids are single-patient products and are intended for single use only. They must not be
cleaned or disinfected.
VIII. WARNINGS
Patients must be trained by medical professionals on how to use the Fahl tracheostomy tubes safely.
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IX. DIRECTIONS FOR TUBE INSERTION AND REMOVAL
For the Doctor/Physician
The appropriate tracheostomy tube must be selected by a doctor/physician or trained medical
professionals.
Select a tube that fits the patient's anatomy to optimise comfort and ventilation (breathing in
and out).
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