Atos Medical PROVOX NiD User manual

Voice Rehabilitation System
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Prescription information
CAUTION: United States Federal law restricts this device
to sale, distribution and use by or on order of a physician
or a licensed practitioner. The availability of this product
without prescription outside the United States may vary
from country to country.
Disclaimer
Atos Medical offers no warranty - neither expressed nor
implied - to the purchaser hereunder as to the lifetime of
the product delivered, which may vary with individual use
and biological conditions. Furthermore, Atos Medical offers
no warranty of merchantability or fitness of the product for
any particular purpose.
Patents and trademarks
Provox
®
and Provox
®
NiD
™
are trademarks of Atos Medical
AB and the products are protected by US patent no. 8.236.007
as well as other patents and patents pending.
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Contents
ENGLISH .................................................9
FRANÇAIS ........................................... 19
PORTUGUÊS....................................... 31
ORDERING INFORMATION........... 43
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ENGLISH
The Instructions for Use, which accompanies this product,
may be revised from time to time and must therefore be
reviewed prior to each procedure in which the product is used.
Contents
Part I: General and user information .................................. 10
Glossary......................................................................................... 10
Intended use ............................................................................... 10
CONTRAINDICATIONS.............................................................. 10
Description of the device ....................................................... 11
WARNINGS ................................................................................... 11
PRECAUTIONS............................................................................. 12
Adverse events........................................................................... 12
Instructions for use................................................................... 13
Inspecting the package and Provox NiD before use 13
Using the Provox NiD to speak......................................... 13
General preparation for maintenance........................... 13
Voice prosthesis removal.................................................... 14
Voice prosthesis insertion .................................................. 14
Cleaning the Provox NiD..................................................... 15
Device lifetime............................................................................ 15
Troubleshooting: - Events by symptom ............................ 15
Ordering information............................................................... 17
User assistance information .................................................. 17
Part II: Prescriber Information............................................... 17
User selection ......................................................................... 17
General requirements...................................................... 17
Removal of safety medallion......................................... 17
User training and counseling........................................ 18
Choosing the right voice prosthesis............................... 18
Additional Information........................................................ 18
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Part I: General and user
information
Glossary
Clinician Medical professional or licensed speech
and language therapist / pathologist or
clinical specialist nurse who is trained in
voice rehabilitation procedures.
HME
Heat and Moisture Exchanger (Artificial
Nose). Device that retains the heat
and moisture in the exhaled air, which
otherwise is lost when breathing through
a tracheostoma.
PE-Segment
Pharyngo-esophageal segment. The
part of the esophagus (food pipe) where
sound is created by vibration of tissue
when using a voice prosthesis.
Silicone
A latex-free material often used in
medical devices
TE-puncture
Small artificial opening created between
the trachea (wind pipe) and the esophagus
(food pipe).
Tracheostoma
Breathing opening in the front of the
neck, where the windpipe is connected
to the skin (also called ‘stoma’).
Voice prosthesis A one-way valve with retaining flanges
inserted into a TE-puncture to allow
speech by redirecting air to the esophagus
(food pipe) while reducing the risk of
food and liquids entering the trachea
(wind pipe).
Intended use
The Provox NiD voice rehabilitation system is intended for
use in prosthetic voice rehabilitation after total laryngectomy
only by patients who have been trained in the use of the
device and, as assessed by the clinician who prescribes
the device, have demonstrated the ability to understand
and consistently follow the Instructions for Use without
clinician supervision.
The Provox NiD is intended for single patient use.
CONTRAINDICATIONS
• Provox NiD is NOT intended for immediate insertion at
the time of tracheo-esophageal puncture.
• Provox NiD may be contraindicated for patients with
bleeding disorders or who are undergoing anticoagulant
treatment. These patient categories need to be carefully
and regularly assessed by their clinician for the risk of
bleeding from the puncture.
• A small tracheostoma may make it difficult or
impossible to insert or replace a Provox NiD Voice
Prosthesis through the stoma.
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Description of the device
Provox NiD Voice Prosthesis and Inserter
The Provox NiD Voice Prosthesis is available in two outer
shaft diameters (17 and 20 French) and several lengths.
Each voice prosthesis comes individually packaged
with a non-sterile, reusable NiD Inserter. For further
information, see Ordering Information at the end of this
Instructions for Use.
Provox NiD Voice Prosthesis (Figure 1)
(1) Silicone valve flap
(2) Radio-opaque valve seat
(3) Voice prosthesis shaft
(4) Esophageal flange
(5) Tracheal flange
(6) Voice prosthesis tip
(7) Safety strap
(8) Safety medallion with thread
(9) Size information (diameter and length between flanges).
Available sizes: 6, 8, 10, 12, 14 and 18 mm.
(10) Outer Diameter:
Provox NiD 17: 5.67 mm (17 Fr)
Provox NiD 20: 6.67 mm (20 Fr)
Provox NiD Inserter (Figure 2)
(1) Inserter tip
(2) Bendable inserter shaft
(3) Safety strap retainer
(4) Release lever
(5) Handle
Materials:
Voice prosthesis: Silicone rubber and fluoroplastic.
Medallion and thread: Silicone rubber and polypropylene.
Inserter: Polypropylene.
Accessories for use with Provox NiD Voice
Prosthesis
The Provox NiD has a full range of accessories for the care
and maintenance of the voice prosthesis. These accessories
include: a Provox Dilator (Figure 3) for dilatation of the
puncture prior to insertion; a Provox Brush (Figure 4) and a
Provox Flush (Figure 5) for daily cleaning. The accessories
are available in different diameters and sizes corresponding
to the diameter and length of the voice prosthesis used.
Recommended lubricants
The recommended water-soluble lubricants are:
KY Jelly®; SurgiLube®; Xylocaine®/(lidocaine) Jelly.
CAUTION: Lubricants that are not water-soluble should
not be used at any time.
WARNINGS
• Never remove the safety strap.
• Never remove the safety medallion without
consulting your clinician first. The medallion is
important for your safety. It helps reduce the risk of
injury in the event that your voice prosthesis dislocates
and falls into the trachea. Only your clinician can decide
whether you can use the voice prosthesis without the
safety medallion, after assessment of the retention of
the voice prosthesis in your puncture. For subsequent
replacements of the voice prosthesis you can remove
the safety medallion yourself. The retention of the voice
prosthesis in the puncture must however be checked
regularly by your clinician, who will decide the interval
for these checkups.
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• Never remove the voice prosthesis from the puncture
without immediately inserting a Provox Dilator or
new voice prosthesis. This may result in aspiration
and/or shrinkage or closure of the puncture, which may
necessitate dilatation or re-puncture by a clinician.
PRECAUTIONS
To reduce infection risk:
• Make sure that your hands are thoroughly clean
and dry before using your hands in the area of your
tracheostoma, and before cleaning your voice prosthesis
and/or accessories.
• Keep all devices clean that may enter or make any
contact with your tracheostoma and voice prosthesis.
To reduce risk of product damage:
• Only use drinking water for cleaning. Never use
detergents other than the ones your clinician has
recommended. Detergents may weaken or damage the
product or may be absorbed by the product which could
cause tissue reactions.
• Only use recommended water-soluble lubricants. Oil-
based lubricants (e.g., Vaseline) may weaken or damage
the product and should never be used .
• Only use genuine Provox accessories for the handling
and cleaning of your voice prosthesis.
To reduce risks when using the device in
combination with other products:
• If you use stoma attachment devices (e.g., adhesives,
laryngectomy tubes, or stoma buttons), make sure you
do not hook the tracheal voice prosthesis flange, safety
strap, medallion, or medallion thread. This may lead to
pulling the voice prosthesis out of the puncture.
• If you use a laryngectomy tube or stoma button, make
sure that the device does not exert pressure on the voice
prosthesis. This may lead to severe tissue damage and/
or accidental swallowing of the voice prosthesis.
Adverse events
Consult your clinician if:
• Any changes occur in the appearance of the material of
the prosthesis or the way it fits in the puncture.
• You frequently suffer from coughing during drinking,
and cleaning the prosthesis does not resolve it. This
may be a an early sign of leakage through or around the
prosthesis.
• Speaking becomes difficult (requires higher effort) and
cleaning the prosthesis does not resolve it.
• There are any signs of inflammation or tissue change at
or near the puncture tract. Symptoms may include, but
are not limited to, pain, heat, redness, and swelling.
• You have bleeding or overgrowth of tissue around the
device.
• You have persistent pain or discomfort in the region of
the Provox NiD.
• You experience chronic cough, trouble breathing, or
blood in the mucus. These can be signs of a serious
health condition that requires medical attention.
If you have lost the device from the puncture, swallowed,
or aspirated the voice prosthesis contact your clinician
immediately.
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Instructions for use
Inspecting the package and Provox
NiD before use
Always carefully inspect the product prior to each use
(i.e. before insertion), and replace if needed. Never use the
product if the package is damaged or opened. Make sure that:
• the valve flap of the voice prosthesis closes against the
valve seat (Figure 1:1, 2). Improper closure can lead to
aspiration of fluids, which may result in coughing and/
or serious lung injury.
• the voice prosthesis is intact (i.e., no tears, cracks, or
other structural damage) (Figure 1:3-6).
• the safety strap is intact (Figure 1:7). Hold the tracheal
flange of the voice prosthesis between two fingers and
gently pull the safety strap (Figure 7). If the safety strap
appears stiff, weak or brittle, or if it shows any kind of
damage, do not use the voice prosthesis and obtain a
replacement.
• the safety medallion and thread, if used, are intact and
connected to the voice prosthesis (Figure 1:8). Hold
the tracheal flange of the voice prosthesis between two
fingers and gently pull the medallion (Figure 8). In
addition, carefully inspect the openings where the thread
is attached to the voice prosthesis and the medallion. If
the safety medallion and/or thread are damaged, do not
use the voice prosthesis.
Using the Provox NiD to speak
When you close off your tracheostoma, you can direct
the air from your lungs through the prosthesis into your
esophagus. That air stream causes vibration of the tissues
in your esophagus, which produces the sound of your voice.
You can speak by using a Heat and Moisture Exchanger
like the Provox HME, using a handsfree speaking device
like Provox Freehands HME or by occluding your stoma
directly with a finger.
An HME may improve pulmonary function and also
facilitates stoma occlusion and speaking. A handsfree device
enables speech without the need to close the tracheostoma
by a finger.
General preparation for maintenance
Caution: Before use or maintenance of the voice prosthesis
or use of any of the accessories, make sure that you have
read and understand the Instructions for Use accompanying
the products. It is also recommended that you fully practice
all maintenance procedures under the supervision of
your clinician before you perform any voice prosthesis
maintenance on your own.
Make sure that your hands are thoroughly clean and dry
before using your hands in the area of your tracheostoma,
and before cleaning your voice prosthesis and/or accessories.
Avoid swallowing while the puncture is open. This may
lead to aspiration of saliva and/or coughing. To reduce the
risk of such aspiration and/or coughing, try keeping your
mouth open while you replace the voice prosthesis (this
prevents you from swallowing).
Do not maintain, remove or replace the voice prosthesis
directly after a meal. This may lead to gagging and/or
vomiting.
It is recommended that you alternate between two voice
prostheses in order to facilitate voice prosthesis maintenance
and to reduce the risk of aspiration, shrinkage and/or closure
of the puncture.
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Prepare
Have the following items ready: voice prosthesis of the same
size and diameter, a Provox Dilator (if used), hypoallergenic
tape (or Provox Silicone Glue), and a water-soluble lubricant.
Also make sure that you have a magnifying mirror and
sufficient light to illuminate the tracheostoma.
1. Attach an intact, clean Provox NiD onto the Provox
NiD Inserter.
2. Secure the voice prosthesis. Attach the safety strap to
the inserter by placing it along the inserter shaft into
the strap retainer area.
Caution: Close the strap retainer flap and make sure
that it is locked (Figure 12 and 13).
3. Put the voice prosthesis on the tip of the inserter.
The safety strap should now be under slight tension
(Figure 14).
4. Lightly lubricate the tip of the voice prosthesis with
water-soluble lubricant (see section “Recommended
Lubricants”) (Figure 15).
Voice prosthesis removal
Prepare the Provox Dilator by lightly lubricating the tip with
water-soluble lubricant (Figure 9). Avoid touching any part
of the Provox Dilator that will be inserted into the puncture.
To remove the voice prosthesis, first carefully loosen
the safety strap from the skin while retaining the voice
prosthesis in the puncture by gently pushing on it with a
finger. Hold the safety strap of the voice prosthesis securely
and pull the voice prosthesis carefully out of the puncture
(Figure 10). Never use the medallion or the medallion thread
to pull out the voice prosthesis.
Gently insert the Provox Dilator into the puncture until you
reach the stop in front of the Provox Dilator handle. Tape
the medallion to the skin, away from the stoma (Figure 11).
Voice prosthesis insertion
If your puncture is situated at an angle within your stoma,
you may bend the Provox NiD Inserter slightly (Figure 16).
Be aware that after bending the shaft you should not rotate
the inserter when placing the voice prosthesis.
1. Carefully remove the Provox Dilator (if used) from the
puncture (Figure 17).
2. Hold the inserter firmly with one hand with the safety
strap release lever pointing upwards.
Caution: Avoid touching the release lever (Figure 18).
3. Gently insert the Provox NiD Voice Prosthesis into
the TE puncture, until the tracheal flange reaches the
tracheal mucosa (Figure 19, 20).
4. Gently move the inserter back and forth and if the
inserter is not bent rotate it slightly (Figure 21) to make
sure that the esophageal flange has unfolded correctly.
When the esophageal flange has unfolded, press the
release lever to free the safety strap (Figure 22).
5. Gently remove the inserter from the puncture while
holding the safety strap of the voice prosthesis against
the skin of your neck (Figure 23). The voice prosthesis
should stay properly in place.
6. Use a piece of tape or Provox Silicone Glue to attach
the safety strap and safety medallion (if used) to the
skin (Figure 24).
7. Clean the Provox NiD Inserter and let dry (Figure 25).
The insertion and/or removal procedures may cause
temporary bleeding. Consult with your clinician immediately
if such bleeding persists.
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Cleaning the Provox NiD
In order for you to speak with your voice prosthesis, the
prosthesis needs to be clean so that air can pass through
it. Regular cleaning of the prosthesis also helps to prolong
device life.
Cleaning the voice prosthesis after removal
Clean the used voice prosthesis using drinking water. Use
the Provox Brush to remove all debris from both the inside
and outside of the voice prosthesis. After cleaning, put the
voice prosthesis on clean gauze and let it dry. Make sure
that the voice prosthesis is stored at room temperature and
that it is protected from heat and direct sunlight.
CAUTION: Avoid using detergents to clean the voice
prosthesis other than those recommended by your clinician.
Cleaning the voice prosthesis inside the puncture
CAUTION: Never clean the voice prosthesis inside the
puncture if the safety medallion has been removed
without a clinician’s recommendation, or if the medallion
is damaged. The medallion is important to your safety. It
helps reduce the risk of injury in the event that your voice
prosthesis dislocates and falls into the trachea. The strap
must be secured to the skin when cleaning the V P inside
the puncture.
Before cleaning the voice prosthesis, make sure the
safety strap of the voice prosthesis is secured to the skin.
Additionally, when cleaning the voice prosthesis inside
the puncture, secure the safety strap by pressing it against
the skin with a finger.
Prior to use, carefully read the Instructions for Use that
accompanies Provox Brush and Provox Flush.
• Brushing the prostheses with the Provox Brush twice
a day and after each meal removes mucus and food
remnants from the prosthesis.
• Flushing the prosthesis with the Provox Flush also helps
to clean debris and mucus from the prosthesis, which
can help increase the life of the device.
Note: The Provox Flush is intended for use only by
patients who have been assessed by the clinician to
be able to consistently follow the instructions for use
without clinician supervision.
• Some dietary measures, like the daily intake of yogurt or
butter milk containing lactobacilli, are considered to be
helpful against excessive Candida growth.
CAUTION: Only use genuine Provox accessories that
are intended for use with Provox NiD when cleaning your
prosthesis. Other devices may cause personal injury or
damage to the voice prosthesis.
Device lifetime
If the voice prosthesis functions properly and has no
structural damage , it may be used for a maximum period of
6 months. If the voice prosthesis does not function properly,
and cleaning does not solve the problem, discard the device
and replace it with a new one immediately.
Troubleshooting: - Events by symptom
Coughing (triggered by drinking or eating) while the
prosthesis is in place.
Most common reasons: Leakage through or around the
prosthesis.
What to do: Clean the prosthesis with the Provox Brush
and/or Flush. There may be food remnants preventing
the valve from closing. If cleaning does not solve the
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problem, discard the device and replace it with a new one
immediately. If replacement of the voice prosthesis does
not improve symptoms, you may have leakage around the
voice prosthesis. Consult with your clinician immediately.
Speaking becomes more and more difficult.
Most common reasons: Valve obstruction, tissue swelling
in the throat (e.g. during radiotherapy).
What to do: Clean the prosthesis with the Provox Brush
and/or Flush. There may be food remnants increasing the
airflow resistance. If cleaning does not improve symptoms,
stop using the voice prosthesis and replace it with a new
one immediately. If replacement of the voice prosthesis
does not improve symptoms, consult with your clinician
immediately.
Insertion of the voice prosthesis into the puncture is
difficult.
Possible causes: Shrinkage of puncture. Swelling of tissue,
excessive tissue, or deformation of the puncture. Not enough
lubricant on the voice prosthesis.
What to do: Stop insertion immediately, and instead gently
insert a Provox Dilator of the correct size. With the dilator
in place, wait for a few minutes and then retry inserting
the voice prosthesis with some lubricant on its tip. If the
difficulties continue, leave the dilator in place and consult
with your clinician immediately.
CAUTION: DO NOT leave the puncture empty after
removal of your voice prosthesis; always insert the dilator
or a voice prosthesis. The puncture may shrink, requiring
dilatation or re-puncture by a clinician.
Inability to insert dilator.
Possible causes: Shrinkage of puncture. Deformation of
the puncture:
NEVER use force to insert the dilator. Consult with your
clinician immediately.
After insertion, voice prosthesis slides out from the
puncture.
Possible causes: Too much lubricant used during voice
prosthesis insertion. Enlarged puncture.
What to do: If too much lubricant was used, wipe off the
excess lubricant and reinsert the voice prosthesis. Secure
the safety strap to the skin and hold the voice prosthesis
with a finger in place. A warm drink may help to dissolve
the lubricant on the esophageal side.
If the puncture is enlarged, you may also notice leakage,
even if the voice prosthesis is clean and intact. This can be
observed as leakage around the voice prosthesis, instead of
through the voice prosthesis. Consult with your clinician
immediately if this is the case.
Pain, heat, swelling, and/or rash in the area of the
puncture or stoma.
Possible causes: Tissue inflammation and/or infection.
What to do: Consult your clinician immediately. If you
experience persistent bleeding from the puncture, seek
immediate medical attention.
Voice prosthesis cannot be seen from outside; safety
medallion thread leads into the puncture.
Possible causes: Accidental dislodgement of the voice
prosthesis in the direction of the esophagus.
What to do: Grasp the safety strap and pull the voice
prosthesis carefully back in place. If the strap is not
visible, grasp the thread of the safety medallion as close
as possible to the puncture. Gently pull the thread in the
direction of the puncture. As soon as the safety strap or
voice prosthesis flange appears, grasp it and pull the voice
prosthesis correctly in place.
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If pulling the thread is not successful, gently dilate the
puncture by inserting the Provox Dilator (while holding
the thread that remains in the puncture), remove the Dilator
and retry the pulling procedure described above. If still not
successful, gently insert the Provox Dilator again (while
holding the thread that remains in the puncture) to avoid
puncture shrinkage. Consult with your clinician immediately.
Voice prosthesis falls into trachea and safety medallion
is at the level of the tracheostoma:
What to do: Breathe calmly and remove the voice prosthesis
from the trachea by gently pulling the medallion up. Insert
a Provox Dilator into the puncture, and prepare and insert
a clean voice prosthesis. If the voice prosthesis falls into
the trachea more than once, consult with your clinician
immediately.
Voice prosthesis is missing and safety medallion is
removed:
Possible causes: Accidental swallowing or accidental
aspiration of the voice prosthesis. Voice prosthesis may
have been dislodged and misplaced outside the body or
voice prosthesis is hidden under tissue in the puncture tract.
What to do: If the voice prosthesis cannot be coughed up
at once or is not found, gently try to insert a Provox Dilator.
Breathe calmly and seek immediate medical attention to
find and if necessary remove the voice prosthesis. The blue
ring inside the voice prosthesis can be detected by X-ray.
Ordering information
See end of the Instructions for Use.
User assistance information
For additional help or information please see back cover of
the Instructions for Use for contact information.
Part II: Prescriber information
User selection
General requirements
Potential users of the Provox NiD must have sufficient
cognitive ability, manual dexterity, and visual acuity to
understand and follow both the Instructions for Use supplied
with this device and the directions furnished by the clinician
in the exercise of his or her independent medical judgment.
It is the responsibility of the prescribing clinician to assess
and ensure complete user compliance with all warnings,
precautions and instructions appropriate to the use of this
device. Also consider aging, it is recommended that the
prescribing clinician determines each patient’s ability and
understanding regarding use of the product at least once
a year. If the patient no longer fulfills the requirements
consider conversion to an indwelling voice prosthesis.
If you doubt in any way that your patient fulfills all of the
above criteria, including without limitation that he or she
has fully understood the information you have provided
in the exercise of your independent medical judgment, do
not prescribe the Provox NiD voice rehabilitation system.
Removal of safety medallion
If the patient wishes to use the voice prosthesis without
the safety medallion it is the responsibility of the clinician
to determine if the retention of the voice prosthesis in the
TE puncture is sufficient to do so. The retention of the voice
prosthesis must also be checked regularly at an interval
determined by the clinician to ensure that changes in the
puncture have not compromised the retention of the voice
prosthesis.
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User training and counseling
Each user must be fully instructed as to the procedures,
risks, and other information deemed necessary by the
clinician, including adverse events, their symptoms, and
all necessary and appropriate actions to be taken by the
user in the event that such adverse events occur.
Choosing the right voice prosthesis
Diameter
Provox NiD prostheses are available in outer shaft diameters
of 17 and 20 Fr (5.67 and 6.67 mm, respectively). Although
both voice prosthesis types are optimized for minimum
airflow resistance at normal speech loudness, the 20 Fr
diameter voice prosthesis has lower airflow resistance,
which may allow for easier voicing.
Use a Provox NiD Dilator of the size corresponding to
the selected voice prosthesis to ensure that the pathway of
the voice prosthesis is the appropriate size prior to insertion.
To allow for an increase from 17 Fr to 20 Fr, dilate the
puncture first using the Provox NiD 20 Dilator.
Note: The Provox Dilators will dilate the puncture tract
slightly more than the corresponding voice prosthesis size,
i.e., the Provox Dilator 17 has a 19 Fr shaft diameter, and
the Provox Dilator 20 has a 22 Fr shaft diameter, in order
to facilitate voice prosthesis insertion.
Length
A too short or long voice prosthesis may cause severe tissue
damage and/or problems with speech.
Always check the appropriate length of the voice
prosthesis. Use the old voice prosthesis in place to check
the size required or use a Provox Measure to determine
the appropriate size.
Additional information
Compatibility with antifungal medicine
Chemical substances may influence the material properties
of the device or may be absorbed by the material and
subsequently released at a later time. Therefore, the
introduction of antifungal medicines or drugs directly to
or within close proximity of the voice prosthesis should
be carefully assessed.
Laboratory tests show only minor negative influence
on the function of the Provox NiD Voice Prosthesis
and components when using the following antifungal
medications:
- Nystatin (Mycostatin®, Bristol-Myers Squibb, NY, USA).
- Fluconazole (Diflucan®, Pfizer, NY, USA).
Compatibility with cleaning detergents
The preferred method to clean the Provox NiD is to use
drinking water without any detergents, as described in the
User Manual, chapter “Cleaning the Provox NiD”.
However, laboratory tests show only moderate negative
influence on the function of the Provox NiD Voice Prosthesis
and components with repeated short-term exposure no more
than 15 minutes per day to: (listed in the order of increasing
negative effect on device function).
- Efferdent Anti Bacterial Denture Cleanser
(Pfizer Consumer Healthcare, NJ, USA),
- Ethanol 70%,
- Hydrogen peroxide (3%) solution.
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FRANÇAIS
Le mode d’emploi qui accompagne ce produit peut être
révisé périodiquement et doit donc être revu avant chaque
procédure au cours de laquelle le produit est utilisé.
Table des matières
Partie I: Informations générales et pour l’utilisateur ... 20
Glossaire ....................................................................................... 20
Utilisation..................................................................................... 20
CONTRE-INDICATIONS............................................................. 20
Description du dispositif......................................................... 21
AVERTISSEMENTS ...................................................................... 21
PRÉCAUTIONS............................................................................. 22
Complications............................................................................. 22
Mode d’emploi ........................................................................... 23
Inspection de l’emballage et du Provox NiD avant
utilisation.................................................................................. 23
Utilisation de la prothèse Provox NiD pour parler..... 23
Préparation générale pour l’utilisation.......................... 24
Retrait de la prothèse phonatoire ................................... 24
Insertion de la prothèse phonatoire............................... 25
Nettoyage du Provox NiD................................................... 25
Durée de vie du dispositif ..................................................... 26
Problèmes et solutions : Événements par symptôme.. 26
Informations de commande.................................................. 28
Informations sur l’assistance à l’utilisateur ...................... 28
Partie II: Informations à l’attention des prescripteurs. 28
Sélection des utilisateurs.................................................... 28
Conditions générales ..................................................... 28
Retrait du médaillon de sécurité................................ 29
Formation et suivi des utilisateurs............................. 29
Choix de la bonne prothèse phonatoire....................... 29
Informations supplémentaires ......................................... 29
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Partie I: Informations générales
et pour l’utilisateur
Glossaire
Praticien Médecin ou orthophoniste diplômé ou
infirmière clinicienne spécialisée formée
aux méthodes de réhabilitation vocale.
HME
Échangeur de chaleur et d’humidité (Heat
and Moisture Exchanger, HME) (nez
artificiel) Dispositif qui retient la chaleur
et l’humidité de l’air expiré, qui est sinon
perdu lors de la respiration à travers un
trachéostome.
Segment PO
Segment pharyngo-oesophagien. La partie
de l’œsophage (tube alimentaire) dans
laquelle le son est généré par la vibration
du tissu lors de l’utilisation d’une prothèse
phonatoire.
Silicone Matériau sans latex, souvent utilisé dans
les dispositifs médicaux
Fistule trachéo-
œsophagienne
Petite ouverture artificielle créée entre la
trachée (tube respiratoire) et l’œsophage
(tube alimentaire).
Trachéostome
Ouverture pratiquée sur le devant du cou,
où le conduit respiratoire est relié à la peau.
Prothèse
phonatoire
Valve unidirectionnelle dotée de
collerettes de retenue, insérée dans une
fistule TO pour permettre la phonation
en redirigeant l’air vers l’œsophage (tube
alimentaire) tout en réduisant le risque de
pénétration de la nourriture et des liquides
dans la trachée (tube respiratoire).
Utilisation
Le système de réhabilitation vocale Provox NiD est destiné à
la réhabilitation vocale prothétique après une laryngectomie
totale uniquement chez des patients ayant été formés à
l’utilisation du dispositif et ayant fait preuve de leur capacité
à comprendre et à suivre fidèlement le mode d’emploi sans
la supervision du praticien prescripteur.
Le Provox NiD est destiné à une utilisation sur un seul
patient.
CONTRE-INDICATIONS
• Provox NiD n’est PAS destiné à une insertion immédiate
au moment de la ponction trachéo-œsophagienne.
• Provox NiD est contre-indiqué chez les patients
présentant des troubles hémorragiques ou sous traitement
anticoagulant. Ces catégories de patients doivent faire
l’objet d’évaluations soigneuses et régulières par leur
praticien quant aux risques d’hémorragie au niveau de
la fistule.
• L’insertion ou le remplacement d’une prothèse
phonatoire Provox NiD dans le cas d’un trachéostome
de petite taille peut s’avérer difficile, voire impossible.
Unregistered copy