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Instructions for Use for
TRACOE
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 doctors and oth-
er trained staff responsible for the patients' care! The attending
doctor must determine the correct size and type.
Intended Purpose: This medical device is a tracheostomy tube.
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 by inflating it
with air using the inflation line. When inflated, the cuff seals the
space between the trachea and the outer cannula wall. This al-
lows efficient ventilation with ventilation equipment and prevents
subglottic secretions 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.
•
See below for a more detailed functional description.
Maximum Useful Life of the Tracheostomy Tube:
•
With cuff – 29 days,
•
Without cuff – 5 weeks,
from first use (see section 5 "General Precautions"). This maxi-
mum period of use also includes any periods when the tracheos-
tomy tubes or inner cannulas are not in use.
6
®
twist Tracheostomy Tubes
The illustrations to which the text refers can be
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