Publicidad
Idiomas disponibles
Idiomas disponibles
•
Do not use non-authorized tools to detach 15 mm connector, as this might deform the 15 mm
connector.
•
Occlusion caps/speaking valves must only be used with a deflated cuff to avoid the risk of
suffocation.
EN
•
During insertion and removal of the tube a need to cough or bleeding may occur.
7.
Side Effects
Typical side effects of tracheostomy tubes use include bleeding, pressure points, pain, stenosis,
and skin irritation (e.g. due to moisture), granulation tissue, tracheomalacia, tracheoesophageal
fistula, increased secretion, and swallowing difficulties. In case of an adverse event please contact
a medical professional immediately.
When using ACV, typical side effects include increased secretion, discomfort, hoarseness, cough-
ing, nausea, or laryngeal drying out due to restoring upper respiratory tract (cleaning / tasting /
speaking) functionality.
8.
Functional Description
Caution:
•
It is strongly recommended that a ready-to-use spare device is kept at the patient's bed-
side. Store the spare device under clean and dry conditions.
•
In case of complications during tube insertion it is also recommended to have a spare
device one size smaller available than the tube in use.
•
Safety precautions must be taken in case of complications during the described proce-
dures, in order to provide immediate ventilation through alternative airways, (e.g. trans laryngeal
intubation, laryngeal mask).
8.1
Preparation
This is a sterile device, which enables use within an aseptic environment.
The size of the tube and appropriate length is determined by a physician.
The following functions must be checked immediately prior to use. If the cuff leaks during use,
replace the tube and contact TRACOE Customer Service. If the device fails the initial inspection,
repeat the procedure with a new device. Do not discard the device, and follow instructions pro-
vided in section "Returns and Complaints".
A.
When using the Minimally Traumatic Insertion System
1. Inspect the sterile packaging to ensure it is secure, undamaged and all components are present.
2. Open the package and inspect the device for damages prior to use.
3. Verify that the tube is free of obstruction, the material is not brittle or torn, the cuff is intact, the
inflating or suction lines are not kinked, there are no tears or cuts, the connection between the tube
and the neck flange is stable.
4. Check the HVLP cuff for leakage by inflating with a hand-held manometer, to a pressure of
50 cmH
O (≈ 36.78 mmHg). Watch the filled cuff for 1 minute to detect leakage by pressure
2
decrease / cuff deflation. If the cuff is leak tight, remove all the air with a syringe. Shift the deflated
cuff material towards the neck flange to facilitate its sliding through the stoma.
5. For adjustment of the tube length, ensure, the orange lever on the right-hand side of the flange
is open (lower position "unlocked", see locking symbol on flange). Press the button with spring
element and move the flange along the tube. Release the push button when the flange is in posi-
tion. Push the locking lever upwards ("locked" position) to fix the flange in place (see Image 3).
Caution:
•
Do not move the neck flange with excessive force against the stop near the 15 mm con-
nector to prevent the inflation line of the cuff from being damaged.
•
For correct orientation of the tube and adjustable neck flange, it is essential, that the
30
Publicidad
