Fahl DURACUFF Manual De Instrucciones página 23

CAUTION!
If the DURACUFF Clip is not used, only the following tracheostomy tube versions (without inner
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cannula) may be used for mechanically ventilated patients:
- DURACUFF VARIO tracheostomy tube without inner cannula (versions REF 13000, 13100, 13200)
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- DURACUFF VARIO SUCTION with universal attachment without inner cannula
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(versions REF 13040, 13140, 13240)
CAUTION!
Never use the DURACUFF
clip is impaired or if the clip shows damages such as sharp edges or cracks, since this could lead
to injuries or disconnection. Defective clips must not be used and must be disposed of. Danger
can be avoided by regular checking!
6.1 Preparing for affixing the DURACUFF
connected to a mechanical ventilation system:
The DURACUFF inner cannula with 15 mm swivel connector can be quickly and easily inserted into
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the DURACUFF outer cannula; however, the inner cannula is only firmly attached to the outer cannula
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when the holding prongs of the inner cannula firmly engage the Easy Lock hexagonal connection of the
outer cannula. For inserting the tracheostomy tube, please observe the directions in these instructions
for use. Please note that an obturator can no longer be used if the DURACUFF
affixed before the tracheostomy tube was inserted and the inner cannula has thus already been
inserted into the outer cannula. For complete change of tracheostomy tube, we recommend to slide the
clip onto the neck flange before inserting the tracheostomy tube. Before the tracheostomy tube is used
on the patient, the clip should be subjected to a function check and the handling procedure should at the
same time be practiced several times. Please also observe the following points when attaching the clip:
When attaching the clip to the neck flange from above, avoid pinching the supply tubes on the
tracheostomy tube (suctioning device and supply tube for inflating the cuff).
- Make sure that the inner cannula is correctly fixed in place and that the clip firmly encompasses the
tracheostomy tube.
The DURACUFF Clip can also be attached or removed with the tracheostomy tube lying in place - In
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this way, it is possible to change only the inner cannula without having to remove the outer cannula.
If you apply the clip when the tracheostomy tube is already inserted, please observe the following in
addition to the points named above:
- Attach the clip carefully to avoid damaging the skin or the mucous membrane!
- Attach the clip before the compress which is already in place!
6.2 Affixing and removing the DURACUFF
The DURACUFF Clip adapter for locking the inner cannula with 15 mm swivel connector in place is
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attached to the outer cannula. The clip is a semicircular attachment that is slid onto the neck flange of
the tracheostomy tube from above (see picture 7d). This is done when the inner cannula is already in
the outer cannula. When the clip is seated correctly, the flat, semicircular rear wall of the clip is located
behind the neck flange (see picture 7e) and the front part of the clip firmly encompasses the ring of the
inner cannula. In this way, the inner cannula is correctly fixed in position (see picture 7f).
To remove the inner cannula, detach the DURACUFF
connector) by applying upward pressure at both clip ends. The clip is under tension to achieve firm
fixation of the inner cannula. Therefore, hold you index finger against the edge of the clip from above
when removing the clip in order to prevent uncontrolled movements.
Cleaning and disinfection of the DURACUFF
cleaning and disinfection.
The clip should be replaced after not more than 29 days (reckoned from opening of the sterile package).
As regards period of use and replacement, please also heed the corresponding chapter, Chapter XI
on period of use.
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.
VIII. 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).
The inner cannula can be removed at any time to increase air supply or for cleaning. This can for
instance be necessary if the cannula is clogged up with secretion residues which cannot be removed
by coughing or because no equipment for suctioning off the secretions is available.
For the Patient
CAUTION!
Only insert the tracheostomy tube with the cuff in fully deflated condition (see picture 7a)!
Clip for locking the inner cannula in place if the functionality of the
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Clip on the tracheostomy tube before the patient is
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Clip
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Clip can be performed as described in Chapter IX on
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Clip from the connector (15 mm swivel
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Clip was already
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