Fahl 25900, Инструкция по эксплуатации

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14
EN
N
WARNING!
Should the voice prosthesis come loose from the shunt channel or
during insertion of the placement instrument, there is a risk of aspi -
ration.
In the event of aspiration, it must be attempted to expel the voice pros -
thesis through strong coughing.
If the voice prosthesis cannot be coughed out, it must immediately be
removed surgically.
INSTRUCTIONS FOR
LARYVOX
®
INSERTER (TURQUOISE, REF 25900)
LARYVOX
®
INSERTER EXPERT (BLACK, REF 25910) AND
LARYVOX
®
INSERTER EXPERT SMALL (YELLOW, REF 25915):
1. Mount the voice prosthesis with the tracheal flange on the head of the
placement instrument .
2. Fix the safety thread of the voice prosthesis in place with the opening at
the intended position:
LARYVOX
®
INSERTER (turquoise) position B .
LARYVOX
®
INSERTER EXPERT (black) - if the safety thread cannot
be securely fixed in place at position B , then choose position A .
LARYVOX
®
INSERTER EXPERT SMALL (yellow) position A .
3. Check to ensure that the voice prosthesis is securely seated on the
placement instrument.
4. To achieve better lubrication of the applicator for advancing the voice
prosthesis, you can use the FAHL
®
OPTIFLUID
®
LUBRICANT GEL
( REF 36105 ) included in delivery.
5. Press the oesophageal flange together in forward direction with the
thumb and index finger of one hand .
Push the oesophageal flange forward by approx. 1 cm into the slotted
opening of the applicator using the placement instrument .
6. While doing this, press on the oesophageal flange with the thumb of the
other hand .
At the same time, push the voice prosthesis further into the applicator
with your other hand .
7. Marked positions 1 and 2 are shown on the placement instrument.
Now guide the placement instrument with the voice prosthesis through
the applicator up to the line of marked position 1 .
8. The voice prosthesis can now be introduced into the shunt channel us -
ing the applicator.
9. Cautiously introduce the tip of the applicator into the shunt channel .
10.
Now slowly advance the voice prosthesis through the applicator up to the
line of marked position 2.
The oesophageal flange will open in the lumen of the oesophagus .
Now cautiously retract the applicator via the placement instrument .
11. The tracheal flange opens in the lumen of the trachea.
The applicator can be retracted via the placement instrument
12. The correct position of the voice prosthesis is verified by rotating the
voice prosthesis with the placement instrument and by pulling slightly .
13. If the voice prosthesis can be easily rotated, fix the safety thread in place
using an atraumatic instrument such as e.g. LARYVOX
®
TWEEZERS
( REF 35000 ) and cautiously remove the placement instrument .
14. Perform a phonation test and, where appropriate, a swallowing test with
the patient in order to verify the leakproofness.
15. If the voice prosthesis is in the correct position, cut the safety thread flush
with the tracheal flange.
8.2.4 LARYVOX
®
INSERTER UNIEK REF 25925 (orange)
PLEASE NOTE!
The LARYVOX
®
INSERTER UNIEK is used only and exclusively for the
anterograde placement of the LARYVOX
®
UNIEK Ultra Low Resistance
( REF 25010 and REF 25020) voice prosthesis, 21 or 24 French, in the
scope of voice prosthesis replacement.
N
WARNING!
Should the voice prosthesis come loose from the shunt channel or
during insertion of the placement instrument, there is a risk of aspi -
ration.
In the event of aspiration, it must be attempted to expel the voice pros -
thesis through strong coughing.
If the voice prosthesis cannot be coughed out, it must immediately be
removed by professional medical means.
INSTRUCTIONS:
1. Fit the voice prosthesis with its tracheal flange onto the head of the
placement instrument .
2. Fix the safety thread of the voice prosthesis in place on the placement
instrument at position A .
3. Check to ensure that the voice prosthesis is securely seated on the
placement instrument.