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Instructions for Use for
TRACOE
and Atraumatic Inserter
NOTE:
•
Please read the instructions for use carefully. They are part
of the described product and must be available at all times. For
your own and your patients' safety, please observe the following
safety information.
•
found on the (foldout) illustrated pages at the beginning of these
instructions. The numbers and letters in brackets refer to the re-
spective illustrations and product components of the tracheostomy
tube. The symbols and icons used are explained on pages 1 to 5.
1.
General Information
CAUTION: The product may only be used by trained doctors and
nursing staff. The attending doctor must determine the correct
size and type.
Intended Purpose: This medical device is a tracheostomy tube
with an inserter for a PDT (percutaneous dilation tracheostomy)
using a Seldinger wire Ø 1.27 ± 0.04 mm (e.g. REF 518, not
included in the delivery) and reinsertion.
Functional Description: The tracheostomy tube ensures that
respired air passes through the tracheostoma.
•
The inflated cuff separates the upper from the lower res-
piratory tract, preventing the flow of air from the lungs into the
mouth and nose and vice versa. This ensures that the patient can
breathe only through the tube. The cuff is inflated with air using
the inflation line. When inflated, the cuff seals the space between
the trachea and the outer cannula wall. This allows efficient ven-
tilation with ventilation equipment and prevents subglottic secre-
tions from entering the lower respiratory tract.
•
Fenestrated cannulas allow some of the air needed for
speaking to reach the upper respiratory tract through the fenestra-
tion. Airway resistance in the upper respiratory tract is also reduced.
•
The atraumatic inserter bridges the gap in diameter.
6
®
twist Tracheostomy Tubes with Cuff
The illustrations to which the text refers can be
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