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• Only fill the H2O Cuff with sterile water. Do not fill the H2O Cuff
with air as this would impair the sealing function of the cuff which may
result in aspiration or VAP (ventilator associated pneumonia).
• The H2O Cuff is an HPLV (high pressure low volume) cuff there-
fore, the measured cuff pressure is not related to the actual cuff pres-
sure exerted on the tracheal wall.
• Before deflating the H2O Cuff (removal of sterile water), ensure
that the patient’s upper respiratory tract is unobstructed. When appli-
cable, clear the upper respiratory tract of any secretions through suc-
tion and if possible patient coughing.
• Do not overfill the H2O Cuff, as this poses a risk of permanent
damage to the trachea.
• Insufficient filling of the H2O Cuff could result in an increased
risk of aspiration or VAP (ventilator associated pneumonia).
• If the cuff leaks during use, replace the tube and contact
TRACOE Customer Service.
• To prevent damage to the stoma or trachea, ensure that the H2O
Cuff is completely deflated (empty) prior to insertion or removal of the
tube (see chapter 8). If it is not possible to deflate the cuff, cut the
inflation line with a pair of scissors and drain the liquid. With this event,
the product is defective and must be replaced.
• Additional proximal extension pieces, i.e. TRACOE kids exten-
sion piece REF 356 are not allowed to be used in combination with an
proximal extended TRACOE silcosoft tube (REF 361, REF 363, REF
371, REF 373).
7. Adverse Reactions
Typical adverse effects during usage of tracheostomy tubes include
pressure points, stenosis, skin irritation, a need to cough, and swal-
lowing difficulties.
Irritation, a need to cough or bleeding may also occur during insertion
and removal of the tube. In the event of an adverse effect, please con-
tact a medical professional immediately.
8. Functional Description
8.1 Preparing the Tube
Note: If the tube fails any step of inspection, repeat the procedure with
a new TRACOE silcosoft tracheostomy tube. Keep the tube with the
batch number when contacting TRACOE Customer Service.
The following functions must be checked immediately prior to use:
• Inspect the sterile packaging to ensure it is secure, undam-
aged and all components are present.
• Open the package and inspect the device for damage prior to
use.
• Ensure the obturator can be easily moved in and out of the tube.
• Ensure the envisaged suction catheter is of appropriate size and
can be easily inserted through the tube.
• If obturator or suction catheter can not be moved easily, please
EN