Teleflex TracheoFlex RUSCH Mode D'emploi page 2

Note:
The enclosed instructions for use are valid for the following products:
TracheoFlex tracheostomy tubes with adjustable fixation flange with or
without cuff.
Warning
Contains DEHP, DBP
The results of certain animal experiments have shown
phthalates to be potentially toxic to reproduction.
Proceeding from the present state of scientific knowledge, risks for male
premature infants cannot be excluded in the case of long-term exposure or
application. Medical devices containing phthalates should be used only
temporarily with pregnant women, nursing mothers, babies and infants.
Set components:
Component
Fixed standard connector
Tightly fitting high-pressure cuff,
valve for Luer and Luer-Lock syringe tip
Mounted adjustable fixation flange
Velcro strap to fix the fixation flange
to the neck
Insertion aid
This tracheostomy tube set is a sterile, reusable product
for single-patient use only.
These instructions for use are primarily directed at the tracheostomised
patient himself as well as at the nursing staff. They should guide them in
how to safely use the tube set, clean it and above all correctly resterilise
it. For this reason, the instructions for use on hand should always be
read by the user, the nursing staff as well as the patient himself.
Caution
This product is delivered in a sterile condition by the manufacturer.
However, sterility is only guaranteed if the packaging is intact.
Do not expose to temperatures above 50 °C.
Indication
Cannulation of tracheotomised patients, particularly in the case of a
narrow tracheostoma and narrow-lumen tracheas. When using cannulas
with cuff, for short-term intermittent inflation.
Diagnosis only by doctor!
Contraindications
• Patients in whom the cuff needs to be inflated for a longer period of time.
• For patients during radiation therapy and magnetic resonance imaging.
Caution
• During surgery on the trachea, use of electrocautery may cause the
tube to burn.
• Protect the tracheostomy cannula from direct laser bombardment
(risk of tube burning)!
• Caution:
In the event of Radiation Therapy where the target organ (cancer) is
adjacent to the location of the cuff on the tube, the cuff material can be
compromised by Radiation and can thus loose its resilient properties.
enInstructions for Use
TracheoFlex Tracheostomy Tubes
With Cuff Without Cuff
   
 
   
   
   
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