Reload Of The Puncture Set; Cleaning And Sterilization; Important Patient Information - Atos Medical Provox Vega Instrucciones De Uso

7. From the cranial side, insert the Guidewire into the narrow end of the Puncture Dilator
and push the Guidewire until it extends approx. 10 cm through the Puncture Dilator
exit hole (Fig. 3.7).
8. Grab the tip of the Guidewire and insert it in the hole next to the exit hole of the
Puncture Dilator (Fig. 3.8).
9. Tighten the Guidewire by pulling it from the narrow end of the Puncture Dilator and
verify that it is secured to the Puncture Dilator (Fig. 3.9).
CAUTION: Ensure that the Guidewire is tightly secured in the Wirelock of the
Puncture Dilator. If the Guidewire is not securely locked into the Wirelock, the
Guidewire could separate from the Puncture Dilator and the Puncture Dilator may
end up in the esophagus requiring retrieval using additional instruments (e.g.,
laryngeal forceps).
10. Using a continuous, smooth motion; dilate the puncture site by carefully pulling the
Guidewire through the puncture site until the thick end of the Puncture Dilator has
passed the puncture. During dilatation, support the TE tissue (for example with two
fi ngers) to reduce dilatation force. For better control, fi rmly grasp the Guidewire
close to the Puncture Dilator (Fig. 3.10).
CAUTION: Dilatation and integral placement of the voice prosthesis should be
carried out in the anterior/caudal direction with limited lateral movement in order
to limit the force applied to the TE wall.
11. In the same continuous, smooth motion, carefully pull the Guidewire, Puncture
Dilator and the Puncture Dilator loop through the puncture. The Puncture Dilator
loop folds the tracheal fl ange of the voice prosthesis as the loop is pulled over the
fl ange and through the puncture. The tracheal fl ange unfolds in the trachea when the
loop releases it (Fig. 3.11).
Stop pulling immediately when the tracheal fl ange is released by the Puncture Dilator
loop. If the tracheal fl ange does not unfold completely, it can be rotated in place using
two non-toothed hemostats.
12. Grasp the tracheal fl ange with a non-toothed hemostat, turn the prosthesis in the
correct position and cut the safety strap (Fig. 3.12).

2.2.3 Reload of the Puncture Set

http://www.atosmedical.com/video_provox_vega_puncture_set_reload
CAUTION: Reload of the Provox Vega Puncture Set must not be performed if the voice
prosthesis safety strap has been cut or damaged during the fi rst placement attempt.
If the procedure needs to be restarted the Provox Vega Puncture Set can be reloaded.
In order to reload the system:
1. Push the Guidewire from the narrow end of the Puncture Dilator until the Guidewire
loosens from the Wirelock (Fig. 4.1-4.2).
2. Pull the Guidewire through the Puncture Dilator (Fig. 4.3).
3. Reload the Vega voice prosthesis in the Puncture Dilator ring (Fig. 4.4).
WARNING: The safety strap and tracheal fl ange of the voice prosthesis must be
oriented towards the Puncture Dilator strap and the Wirelock when it is inserted into
the Puncture Dilator loop (Fig. 4.4).
4. If needed, the Guidewire can be straightened to facilitate reinsertion.
5. Proceed according to "2.2 Operating Instructions".

2.3 Cleaning and sterilization

The surgical components in the puncture set, as well as the voice prosthesis, are provided
sterile (EO) and are intended for single use only and can NOT be cleaned or resterilized.
After placement, the voice prosthesis requires regular cleaning by the patient while
the prosthesis remains in situ (see prosthesis maintenance below).

2.4 Important patient information

Inform the patient that:
• After a prosthesis placement traces of blood may be found in the sputum.
• Occasionally, mild leakage through or around the prosthesis may occur in the fi rst
weeks after insertion of a prosthesis. This often resolves spontaneously and does not
require immediate replacement of the prosthesis.
• Speech training sessions with a speech language pathologist are advised in order to
acquire optimal voice sound, fl uent speech, and optimal intelligibility.
Ensure that the patient understands to contact their clinician if:
• Any changes in the appearance of the material of the prosthesis or in the way it fi ts in
the puncture occur.
• Leakage occurs during eating and/or drinking, and cleaning the prosthesis does not
help. Provox Vega Plug can be used for temporary preventing leakage during eating
and drinking until the device can be replaced.
• Speaking becomes diffi cult (requires higher effort) and cleaning does not help.
• There are any signs of infl ammation or tissue change at or near the puncture tract.
• Bleeding or overgrowth of tissue around the device.
• Persistent pain or discomfort in the region of the Vega voice prosthesis.
• Chronic cough, trouble breathing, or blood in the mucus. These can be signs of a serious
health conditions that requires medical attention.
Prosthesis maintenance:
CAUTION: Only use genuine Provox accessories that are intended for use with Provox
Vega when cleaning the prosthesis.
The patient should clean the prosthesis at least twice a day and after each meal with the
Provox Brush by inserting the brush into the prosthesis and moving it gently back and
forth with a twisting movement. After the brush is removed it should be wiped with a
gauze. The procedure can be repeated as often as necessary. For details and how to clean
the brush see Instructions for Use that come with the Provox Brush. In addition to using
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