PROVOX LaryTube Manual De Instrucciones página 16

f) HME and Accessory Holder
g) Wings
h) Ring for adhesive connection
i) Fenestration holes
1.4 WARNINGS
• DO NOT reuse a used Provox LaryTube in another patient. The device is
intended for single patient use only. Reuse in another patient may cause cross
contamination.
• DO NOT use lubricating gels if the patient has allergies related to these
substances.
• DO ensure that the patient has been trained in the use of the device. The
patient should demonstrate the ability to understand and consistently follow
the Instructions for Use without clinician supervision.
1.5 PRECAUTIONS
• Always use a Provox LaryTube of an appropriate size. If the Provox
LaryTube is too wide, too narrow, too long or too short it may cause tissue
damage, bleeding or irritation. In addition, it may be harder to produce
voice, because the LaryTube may obstruct the voice prosthesis. Inserting,
removing and pressing on the HME Cassette may exert pressure on the voice
prosthesis if the Provox LaryTube is not sized appropriately. A LaryTube
that is too narrow may cause the stoma to shrink.
• DO NOT use force during insertion. Always insert and remove the Provox
LaryTube according to the instructions below. If the product is pushed too
far into trachea it may obstruct breathing. The use of force during insertion
may cause tissue damage, bleeding or irritation and accidental dislodgement
of the voice prosthesis and/or XtraFlange if used.
• If fenestration is necessary, make sure that it is done with the Provox
Fenestration Punch. This will ensure that the holes are small and smooth.
Fenestration holes that are too large may cause dislodgement of the voice
prosthesis or XtraFlange. Fenestration holes with sharp edges may cause
formation of granulation tissue. Make sure that no silicone residues are left
in the holes or lumen of the LaryTube after fenestration.
• DO NOT use a dirty or contaminated Provox LaryTube. Clean and disinfect
the device according to the cleaning and disinfection instructions below.
• DO NOT use a damaged device since this might cause aspiration of small
parts or cause formation of granulation tissue.
• Only use water-soluble lubricants. Oil-based lubricants (e.g., Vaseline) may
weaken, damage, or destroy the product and should not be used.
• Carefully monitor the tracheostoma tissue during radiation therapy. Stop
using the device if the stoma gets irritated or starts to bleed.
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