Teleflex TracheoFlex RUSCH Mode D'emploi page 3

In this instance, a visual inspection and functional performance
testing should be conducted to verify that the integrity of the cuff has
not been compromised during radiation therapy.
As the duration and dosage of this therapy can influence the material
capabilities of Poly Vinyl Chloride (PVC), and can therefore increase
the risk of cuff damage, we recommend to check the tube and its
function thoroughly after each applied dose fraction, and to exchange
the tube in the event that performance is affected and / or damage
to the material is observed.
Description
• Shaft
This product consists of a highly flexible, armoured tracheostomy
cannula made of polyvinylchloride (medical grade PVC).
• With cuff / without cuff
When using cannulas with cuff a high filling pressure must be used to
inflate the cuff as it fits very thightly. This pressure does not give any
real information about the actual pressure of the cuff on the tracheal
mucosa. The inflation status of the cuff is indicated by the pilot balloon.
• Fixation Flange
The fixation flange may be moved along the tube shaft and can thus be
individually adapted to the patient's individual anatomy and can be
secured to the tube in optimum position.
Warning!
The graduation on the tube shaft can be used for orientation. It is,
however, not an indication of measurements!
The neck band (velcro band) ensures patient-friendly, gentle fixation of
the flange to the patient's neck and can be adapted to the thickness of
the neck.
Caution:
The tube neckband can not be cleaned and reused (single use only)!
Reprocessing of medical devices intended for single use only may result
in degraded performance or a loss of functionality. Re-use of single use
only medical devices may result in exposure to viral, bacterial, fungal or
prionic pathogens. Validated cleaning and sterilization methods and
instructions for reprocessing to original specifications are not available
for these medical devices. This product is not designed to be cleaned,
disinfected or sterilized.
Delivery form and storage recommendations
This tracheostomy tube set is a sterile reusable product
to be used with one patient only.
Each set is supplied in an individual sterile pouch.
For the sterilisation method used see product label.
Sterility of the set and its components can only be guaranteed as long
as the packaging has not been opened or damaged.
Do not resterilise this product and do not use beyond its expiry date,
but dispose!
This product should be stored in dry surroundings, preferably away from
direct or indirect sources of heat and light.
Store in cool surroundings, protected form light and ozone (if applicable,
no ultraviolet light)! Avoid high temperatures.