Atos Medical PROVOX Vega User manual

Voice Prosthesis with SmartInserter™
Clinician’s Manual
Region 2
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A
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2) SmartInserter™ System
a) Guide
b) Connection Side
c) Folding Device
d) Distal tip
e) Inserter Pin
f) Voice prosthesis
g) Loading Tube
h) Step marker
i) Tip
Illustrations
1) Provox®Vega™ voice prosthesis
a) Size information (shaft diameter and length between anges)
b) Prosthesis Hood
c) Esophageal Flange
d) Tracheal Flange
e) Safety Strap
f) Valve Flap
g) Prosthesis Shaft
h) Radio-opaque uoroplastic Valve Seat (resisting candida
growth)
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3) Insertion
a)
b)
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d)
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b) c)
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4) Over-shooting
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a)
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g) h) i)
b 1)
e) f)
c) d)
b 2)
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5) Re-loading
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CONTENTS
ENGLISH .....................................................................8
DANSK.......................................................................17
NORSK.......................................................................27
SUOMI.......................................................................37
......................................................................................47
한국어 .......................................................................56
......................................................................................65
日本語版
繁體中文
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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 tness of the product for any particular purpose.
Patents and trademarks
Provox
®
is a registered trademark owned by Atos Medical AB,
Sweden. Provox®Vega™is protected by US 5.976.151, JP 4.122.058
as well as other patents and patents pending.
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ENGLISH
Provox® Vega™
The manual, 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
1. Descriptive information...............................................................9
1.1 Indications for use.......................................................................9
1.2 Description of the device .........................................................9
1.3 Contraindications........................................................................ 9
1.4 WARNINGS .....................................................................................9
1.5 PRECAUTIONS.............................................................................10
2. Instructions for use..................................................................... 10
2.1 Preparation ..................................................................................10
2.2 Anterograde replacement procedure................................10
2.3 Anterograde replacement procedure
using voluntary overshooting .....................................................11
2.4 Reloading the Provox SmartInserter ..................................12
3. Important patient information ..............................................13
3.1 General information.................................................................13
3.2 Prosthesis maintenance..........................................................13
3.3 Accessories ..................................................................................13
4. Adverse events/Trouble shooting information................ 14
5. Additional information.............................................................16
5.1 Compatibility with MRI, X-ray and radiation therapy...16
5.2 Device lifetime............................................................................16
5.3 Date of printing..........................................................................16
5.4 User assistance information ..................................................16
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1. Descriptive information
1.1 Indications for use
The Provox Vega Voice Prosthesis is a sterile single use indwelling
voice prosthesis intended for voice rehabilitation after surgical
removal of the larynx (laryngectomy). Cleaning of the voice
prosthesis is performed by the Patient while it remains in situ.
The Provox SmartInserter is a sterile single use device intended
for anterograde replacement of the Provox Vega Voice Prosthesis.
This replacement procedure is carried out by a medical doctor or a
trained medical professional in accordance with local or national
guidelines.
The Provox SmartInserter is not intended to be used for insertion
of a voice prosthesis in a freshly made puncture.
1.2 Description of the device
General
The Provox Vega is a one-way valve (prosthesis) that keeps a
TE-puncture open for speech, while reducing the risk of uids
and food entering the trachea. The Provox Vega voice prosthesis
is not a permanent implant, and needs periodic replacement. The
prosthesis (gure 1) is available in different diameters and several
lengths. The device is made of medical grade silicone rubber and
uoroplastic.
Provox Vega package
The Provox Vega package contains the following items:
• 1 Provox Vega voice prosthesis pre-loaded in a single-use
SmartInserter, sterile (gure 2)
• 1 Provox Brush of a size corresponding to the voice prosthesis,
non-sterile
• 1 Provox Vega Clinician’s Manual
• 1 Provox Vega Patient’s Manual
• 1 Provox Brush Instructions for Use
1.3 Contraindications
There are no known contraindications for use or replacement of
the Provox Vega voice prosthesis among patients already using
prosthetic voice rehabilitation.
1.4 WARNINGS
Dislodgement or extrusion of the ProvoxVega voice prosthesis from
the TE puncture and subsequent ingestion, aspiration or tissue
damage may occur. For further information about these events, see
section Adverse Events/Trouble Shooting Information below.
To reduce the risk of dislodgment/extrusion and its potential
sequelae:
• Select the proper prosthesis size. A tight t may cause tissue
necrosis and extrusion.
• Instruct the patient to consult a physician immediately if there
are any signs of tissue edema and/or inammation/infection.
• If used, choose laryngectomy tubes or stoma buttons with a
suitable shape that do not exert pressure on the prosthesis or
catch onto the tracheal ange of the prosthesis during insertion
and removal of the laryngectomy tube or stoma button.
• Instruct the patient to use only genuine Provox accessories
of corresponding size (Brush, Flush, Plug) for maintenance
and to avoid all other kinds of manipulation.
• Re-use and re-processing may cause cross-contamination and
damage to the device, which could cause patient harm.
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1.5 PRECAUTIONS
• Carefully assess any patient with bleeding disorders or who is
undergoing anticoagulant treatment for the risk of bleeding or
hemorrhage prior to placement or replacement of the prosthesis.
• Inspect the package before use. If the package is damaged or
opened, do not use the product.
• Always use aseptic technique when handling the prosthesis in
order to reduce infection risk.
• Make sure that any external or internal stoma attachment devices
used do not exert pressure or hook the ange of the prosthesis
(e.g., HME base plates, laryngectomy tubes, or stoma buttons).
This may lead to severe tissue damage and/or accidental ingestion
of the prosthesis.
2. Instructions for use
2.1 Preparation
Choosing the right shaft diameter and length of the replacement
prosthesis
Be sure to use a Provox Vega voice prosthesis of the proper shaft
diameter and length. Provox Vega is available in different shaft
diameters and in several lengths.
• Shaftdiameter
The Clinician should determine the proper diameter of the
prosthesis appropriate for the patient.
• If the selected diameter is larger than the previous prosthesis
the tract must be dilated using the Provox Dilator appropriate
to the diameter of the prosthesis being inserted.
• If a prosthesis with a smaller shaft diameter is inserted, it is
important to observe and ensure that the puncture shrinks
to the appropriate diameter.
• Shaftlength
To select the correct length, you may use the current prosthesis
as its own measuring device. If there is too much (i.e. 3 mm /
~0.12 inches, or more) space between the Tracheal Flange of the
old prosthesis and the mucosal wall, a shorter prosthesis should
be used. If the prosthesis sits too tight, a longer prosthesis should
be used.
2.2 Anterograde replacement procedure
(Figures 3a-g)
Activating Provox SmartInserter for replacement
With one hand holding the loading tube, use the other hand to push
the inserter pin partially into the loading tube, until the blue ring
of the prosthesis has passed the step marker of the loading tube
(gure 3a). The Provox Vega voice prosthesis is now ready for
insertion.
Preparing the puncture (optional)
The puncture may be dilated to prepare for the insertion of the voice
prosthesis. This is usually not necessary but may facilitate insertion
in patients with angled or tight punctures that easily collapse.
Inserting the new prosthesis into the puncture
The current (old) prosthesis is removed from the TE-puncture by
pulling out the device with a non-toothed hemostat.
1. Probing the TE-puncture
Hold the Provox SmartInserter by the Loading Tube. Gently
insert the Tip of the Loading Tube (Figure 3b). Proceed with
care if you encounter resistance during insertion of the Loading
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Tube into the puncture. In this case, dilatation and/or lubrication
can ease the insertion.
2. “Injecting” the prosthesis
With one hand holding the loading tube stable in this position,
use the thumb of the other hand to advance the Inserter Pin until
it is completely inserted into the SmartInserter (Figure 3c).
3. Releasing the prosthesis
Pull the SmartInserter straight out from the puncture (Figure 3d).
The prosthesis remains in the puncture; still rmly attached to
the Inserter Pin (Figure 3e).
4.Checkingthepropert
Check to see if the prosthesis is in the proper position by rotating
and exerting slight traction on the Tracheal Flange (Figure 3e).
The oval shape of the Tracheal Flange is helpful in determining
the ideal position of the prosthesis (by pointing downward,
Figure 3g).
5. Test proper function
Test proper function of the prosthesis by asking the patient to
speak and by observing the prosthesis while the patient drinks
water (Figure 3f).
6. Cut the Safety Strap with scissors
When the prosthesis is safely in place, use scissors to cut off the Safety
Strap on the outer edge of the Tracheal Flange (Figure 3g). The oval
end of the Tracheal Flange should point downwards into the trachea.
The Provox Vega voice prosthesis is now ready for use.
2.3 Anterograde replacement procedure
using voluntary overshooting
(Figures 4a-h)
When the puncture tract is very short, or when mucosa folds over
the posterior part of the prosthesis, or when the esophageal ange
is difcult to develop within the esophagus, overshooting can help
to completely develop the esophageal ange of the prosthesis.
Overshooting means that during the insertion procedure, the Provox
Vega voice prosthesis is pushed entirely through the puncture
into the esophagus. The prosthesis Safety Strap remains thereby
attached to the Inserter Pin.
Activating System for replacement using voluntary
overshooting
1. With one hand holding the loading tube, use the other hand to
push the inserter pin partially into the loading tube, until the
blue ring of the prosthesis has passed the step marker of the
loading tube (Figure 4a).
2. Squeeze the Guide between thumb and index nger (Figure 4b).
Push it further into the loading tube (Figure 4c). The Provox
Vega voice prosthesis is now ready for overshoot-insertion.
Inserting the new prosthesis into the puncture -
Overshoot
1. Probing the TE-puncture
Hold the Provox SmartInserter by the Loading Tube. Gently
insert the Tip of the Loading Tube. Proceed with care if you
encounter resistance during insertion of the Loading Tube into
the puncture (Figure 3b). In this case, dilatation and/or lubrication
of the puncture can ease the insertion
2. “Injecting” the prosthesis
With one hand holding the loading tube stable in this position, use
the other hand to advance the Inserter Pin until it is completely
inserted into the SmartInserter (Figure 4d).
As the Guide is being pushed further into the Loading Tube, the
Inserter Pin will advance further and release the Provox Vega
voice prosthesis completely within the esophagus.
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3. Pulling the prosthesis back
Pull the Loading Tube out from the puncture (Figure 4e). Pull the
Provox Vega voice prosthesis back into the puncture by grasping
and pulling the tracheal ange of the prosthesis with a non-toothed
hemostat (Figure 4f).
4.Checkingthepropert
Check to see if the prosthesis is in the proper position by rotating
and applying slight traction on the tracheal ange (Figure 4g). The
oval shape of the tracheal ange should be pointed downwards
(Figure 4g).
5. Test proper function
Test proper function of the prosthesis by asking the patient to
speak and by observing the prosthesis while the patient drinks
water (Figure 3f).
6. Cut the Safety Strap with scissors
When the prosthesis is safely in place, use scissors to cut off the
Safety Strap on the outer edge of the tracheal ange (Figure 3g).
The oval end of the tracheal ange should point downwards
into the trachea (Figure 3f). The Provox Vega voice prosthesis
is now ready for use.
CAUTION: If reloading the SmartInserter after Overshooting,
make sure the Folding device and Guide are assembled in
proper way (see section 2.4 below).
2.4 Reloading the Provox SmartInserter
(Figures 5a-i)
If the rst attempt to insert the Provox Vega voice prosthesis into
the TE-puncture was unsuccessful, it is possible to reload the
Provox Vega into the SmartInserter.
CAUTION: Do not reload the SmartInserter more than 2 times.
If the Provox Vega voice prosthesis shows any signs of damage,
do not use the prosthesis and obtain a replacement prosthesis.
1. Make sure the prosthesis is still safely attached to the Inserter Pin
(Figure 5b1-5b2). If not, secure the Safety Strap on the Inserter
Pin by leading the Safety Strap through the Attachment Hole
in the Inserter Pin (Figure 5c-d).
2. Put the Provox Vega voice prosthesis with the tracheal side down
on top of the Inserter Pin (Figure 5e-f). Use your thumb to ensure
that the voice prosthesis is properly positioned (Figure 5f).
3. Check that the Folding Device and Guide are still assembled in
the upper Guide position. If not, re-assemble the Folding Device
into Guide according to gure 5g. Do not push the Folding
Device in the bottom position of the Guide.
4. Gently pull the Inserter Pin with the attached prosthesis into
the Folding Device until you can clearly hear it click in place
(gure 5h). The Esophageal Flange of the prosthesis is now in
level with the Folding Device.
5. Attach the Loading Tube to the top of the Folding Device / Guide
(Figure 5i) and let the two parts snap together.
The Provox Vega voice prosthesis is now ready for activation
and can be used as described in section “Anterograde
Replacement Procedure” or “Anterograde Replacement
Procedure including voluntary overshooting”.
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3. Important patient information
3.1 General information
Ensure that the patient understands to contact their clinician if:
• There is leakage through or around the prosthesis (coughing
and/or change of mucus color)
• Speaking becomes difcult (higher effort and/or voice sounds
more strained)
• There are any signs of inammation or tissue changes at the
puncture site or the stoma region (pain, redness, heat, swelling,
traces of blood on the brush after brushing)
Also inform the patient that:
• After a prosthesis replacement traces of blood may be found
in the sputum. This may come from granulation tissue on the
edges of the TE puncture.
• Occasionally, mild leakage through or around the prosthesis may
occur in the rst weeks after insertion of a new prosthesis. This
often resolves spontaneously and does not require immediate
replacement of the prosthesis.
• If leakage spontaneously occurs through the prosthesis a
temporary blockage can be done with a Provox Vega Plug.
• Speech Training Sessions with a trained clinician are advised in
order to acquire optimal voice sound, uent speech, and optimal
intelligibility.
3.2 Prosthesis maintenance
Instruct the patient when and how to clean his or her Provox Vega
voice prosthesis. Cleaning the prosthesis at least twice a day can
help prolong the device life.
CAUTION: Only use genuine Provox accessories that are
intended for use with Provox Vega when cleaning the prosthesis.
• Brushing the prosthesis with the Provox Brush twice a day will
help to remove 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 helps increase the
life of the device.
Note: The Provox Flush is intended for use only by patients who,
as assessed by the clinician who prescribes the device, have
demonstrated ability to understand and 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.
For detailed information on how to clean the Provox Vega, please
see Instructions for each accessory.
3.3 Accessories
CAUTION: Only use genuine Provox accessories that are
intended for use with Provox Vega. Other accessories may
cause patient harm or product malfunction.
Accessories to facilitate insertion of the prosthesis (for
clinician’s use)
• Provox Dilator: Helps to convert from a prosthesis with a
smaller shaft diameter to a Provox voice prostheses of larger
diameter.
• Provox Guidewire: for placement of a Provox, Provox2 or
Provox Vega voice prosthesis in a freshly made TE puncture,
or for retrograde replacement of a Provox indwelling voice
prosthesis.
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Accessories to maintain the device function
(for patient’s use)
• Provox Brush / Provox Brush XL is used by the patient to
clean the inside of the prosthesis.
• Provox Flush is an additional cleaning device that allows
ushing of the prosthesis.
• Provox Vega Plug is a First Aid tool for patient’s use that
temporarily blocks leakage through the prosthesis.
Other supplementary products that can be used with
Provox voice prostheses.
• Provox HME: Heat- and Moisture Exchanger partially restores
lost nasal functions (heating, humidifying, breathing resistance).
• Provox FreeHands HME: A Heat and Moisture Exchanger
combined with an automatic tracheostoma valve, designed to
allow hands-free speech.
• Provox LaryTube: A silicone tracheal cannula intended to
support shrinking stomas while retaining other rehabilitation
devices of the Provox System.
• Provox LaryButton: A soft, self-retaining silicone tracheal
cannula intended to support shrinking stomas while retaining
other rehabilitation devices of the Provox System.
4. Adverse events/Trouble shooting
information
The following are possible risks associated with prosthetic voice
rehabilitation:
Prosthesis related
Leakage through the valve – Leakage through the prosthesis
may occur in association with Candida overgrowth of the valve
ap or dislodgement of the radio opaque ring (valve seat). It may
also occur if the esophageal ange of the prosthesis is not fully
developed in the lumen of the esophagus or if the prosthesis is too
short. Endoscopic examination should be performed to determine
whether any of these phenomena has occurred. If the prosthesis
is in the correct position and of the right length, and if cleaning
of the prosthesis does not resolve leakage through the prosthesis,
replacement of the prosthesis is indicated.
Candida overgrowth – Candida overgrowth of the prosthesis occurs
in almost all patients. Radiotherapy, salivary content and dietary habits
may inuence how rapidly Candida can affect the silicone material.
Treatment with antifungal agents may be considered as a preventive
measure if Candida overgrowth causes leakage through the prosthesis
or other incompetence of the valve.
Compatibility with antifungal medicine
An unknown variety of chemical substances may immediately
inuence 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 inuence on the
function of the Provox Vega voice prosthesis and components
when using the following antifungal medications:
• Nystatin
• Fluconazole
• Mikonazol
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Puncture related
Aspiration of the prosthesis – Accidental aspiration of the voice
prosthesis or other components of the voice rehabilitation system
may occur. Immediate symptoms may include gagging, coughing,
choking or wheezing. As with any other foreign body, complications
from aspiration of a component may cause obstruction or infection.
Complications may include pneumonia, atelectasis, bronchitis, lung
abscess, bronchopulmonary stula and asthma. If the patient can
breathe, coughing may remove the foreign body. Partial airway
obstruction or complete airway obstruction requires immediate
intervention for removal of the object.
Ingestion of the prosthesis – Accidental ingestion of the voice
prosthesis, or other components of the voice rehabilitation system,
may occur. As with any other foreign body, the symptoms caused by
ingestion of the prosthesis or component of the voice rehabilitation
system depends largely on size, location, degree of obstruction (if
any) and the length of time it has been present. Ingested components
that have remained in the lower esophagus may be removed by
esophaguscopy or observed for a short period of time. The object
may pass spontaneously into the stomach; foreign bodies that pass
into the stomach usually pass through the intestinal tract. Surgical
removal of foreign bodies in the intestinal tract must be considered
when bowel obstruction occurs, bleeding is present, perforation
occurs or the object fails to pass through the intestinal tract.
Hemorrhage/Bleeding of the puncture – Slight bleeding from
the edges of the TE-puncture may occur during replacement of
the prosthesis and generally resolves spontaneously. Patients on
anti-coagulant therapy, however, should be carefully evaluated
for the risk of hemorrhage prior to placement or replacement of
the prosthesis.
Infection and/or edema of the TE-puncture – Infection,
granulation formation and/or edema of the puncture (e.g during
radio therapy) may increase the length of the puncture tract.
This may cause the prosthesis to be drawn inward and under the
tracheal or esophageal mucosa. Or, inammation or overgrowth
of the esophageal mucosa may cause the prosthesis to protrude
from the puncture. Temporary replacement of the prosthesis by
a prosthesis with a longer shaft is then advisable. Treatment with
broad-spectrum antibiotics with or without corticosteroids may
be considered for treatment of the infection. If the infection does
not resolve with antibiotics and/or corticosteroid intervention in
the presence of the prosthesis, the prosthesis should be removed.
In some cases stenting the puncture with a catheter might be
considered. If the puncture closes spontaneously secondary
to removal of the prosthesis, repuncture for insertion of a new
prosthesis may be required.
Granulation around the puncture – Formation of granulation
tissue around the TE-puncture has been reported at an incidence
of 5%. Electrical, chemical, or laser cauterization of the area of
granulation may be considered.
Hypertrophic scarring around the puncture – Bulging of the
tracheal mucosa over the tracheal ange may occur if the prosthesis
is relatively short. This excess tissue may be removed by using a
laser (CO2, or NdYAG). Alternatively, a prosthesis with a longer
shaft can be used.
Protrusion/extrusion of the prosthesis– Protrusion of the prosthesis
and subsequent spontaneous extrusion is sometimes observed
during infection of the TE-puncture. Removal of the prosthesis is
required to avoid dislodgement into the trachea. The puncture may
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close spontaneously secondary to the removal of the prosthesis.
Repuncture may be necessary for insertion of a new prosthesis.
Leakage around the prosthesis – Transient leakage around the
prosthesis may occur and may improve spontaneously. The most
common reason is that the prosthesis is too long, which is solved
by inserting a shorter prosthesis. A prosthesis of another diameter
(upsizing) can also solve the leakage. If leakage does not improve
(which it often does spontaneously), temporary removal of the
prosthesis and the insertion of a cuffed tracheal cannula and/
or nasogastric feeding tube to permit shrinkage of the puncture
may be considered. Alternatively, a purse string suture with 3x0
absorbable material could be submucosally applied around the
TE-puncture after removal of the prosthesis. The new prosthesis
should be inserted and the suture should be tightened gently,
enclosing the puncture walls around the prosthesis. If leakage
around the prosthesis is intractable, more conservative measures,
surgical closure of the puncture and subsequent repuncture may
be necessary.
Tissue damage – If the prosthesis is too short, too long, or is pushed
frequently against the esophageal wall by a tracheal cannula, stoma
button, or the patients’ nger, damage of the puncture, tracheal
and/or esophageal tissues may occur. In patients undergoing
radiotherapy this may happen more easily. Inspect the conditions
regularly to avoid severe damage.
5. Additional information
5.1 Compatibility with MRI, X-ray and radiation
therapy
Provox voice prostheses have been tested and found to be compatible,
except Provox ActiValve, with Magnetic Resonance Imaging
(tested up to 1.5 Tesla), x-ray and radiation therapy (tested up to
70 Gy). The prosthesis can be left within the TE-puncture during
the examination/therapy session. Note that the radio-opaque valve
seat is visible on x-ray.
5.2 Device lifetime
Depending on individual biological circumstances the device life
varies, and it is not possible to predict the integrity of the device
over a longer period of time. The material of the device will be
affected by e.g. bacteria and yeast, and the structural integrity of
the device will eventually deteriorate.
Laboratory testings of simulated usage for a test period of 12 months
show that, in the absence of bacteria and yeasts, the device will
maintain its structural integrity for this time period. The device
has not been tested for usage beyond 12 months. Usage beyond
this limit is under the sole discretion of the prescriber.
5.3 Date of printing
See version number on the back cover of this manual.
5.4 User assistance information
For additional help or information please see back cover for contact
information.
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Provox® Vega™
Behandlervejledningen, som følger med Provox Vega-pakken,
revideres løbende og skal derfor læses før hver procedure, hvor
Provox Vega-stemmeprotesen anvendes.
Illustrationer
1) Provox® Vega™ stemmeprotese
a) Størrelsesoplysninger (skaftdiameter og længde mellem
angerne)
b) Protesekappe
c) Esophagealange
d) Trachealange
e) Sikkerhedsstreng
f) Ventilklap
g) Proteseskaft
h) Røntgenfast ventilsæde i uoroplast (hæmmer
candidavækst)
2) SmartInserter™ System
a) Styr
b) Forbindelsesside
c) Foldeanordning
d) Distalspids
e) Indføringsstang
f) Stemmeprotese
g) Indføringsrør
h) Afstandsmarkering
i) Spids
DANSK
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Indhold
1. Beskrivelse..........................................................................................19
1.1 Indikationer for brug....................................................................19
1.2 Beskrivelse af enheden................................................................19
1.3 Kontraindikationer........................................................................19
1.4 ADVARSLER......................................................................................19
1.5 FORSIGTIGHEDSREGLER .............................................................20
2. Brugsvejledning ...............................................................................20
2.1 Klargøring ........................................................................................20
2.2 Anterograd udskiftningsprocedure........................................20
2.3 Anterograd udskiftningsprocedure med valgfri
overindføring.........................................................................................21
2.4 Genindføring af Provox SmartInserter...................................22
3. Vigtige oplysninger til patienten................................................22
3.1 Generelt ............................................................................................22
3.2 Vedligeholdelse af protesen......................................................23
3.3 Tilbehør.............................................................................................23
4. Bivirkninger/fejlnding..................................................................24
5. Yderligere information...................................................................26
5.1 Kompatibilitet med MRI, røntgen og strålebehandling..26
5.2 Enhedens levetid...........................................................................26
5.3 Trykkedato .......................................................................................26
5.4 Oplysninger om brugerassistance..........................................26
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1. Beskrivelse
1.1 Indikationer for brug
Provox Vega Voice Prosthesis er en steril stemmeprotese til
engangsbrug, som er beregnet til stemmerehabilitering efter
kirurgisk fjernelse af larynx (strubehovedet), kaldet laryngektomi.
Rengøring af stemmeprotesen udføres af patienten, mens den er isat.
Provox SmartInserter er en steril engangsenhed til anterograd
udskiftning af Provox Vega-stemmeprotesen. Denne
udskiftningsprocedure udføres af en læge eller en kvaliceret
sundhedsmedarbejder i overensstemmelse med lokale eller
nationale retningslinjer.
Provox SmartInserter er ikke beregnet til indsættelse af
stemmeprotese i en ny punktur.
1.2 Beskrivelse af enheden
Generelt
Provox Vega er en envejsventil (protese), som holder en TE-punktur
åben til tale, samtidig med at risikoen for at der kommer væske og
mad i trachea reduceres. Provox Vega-stemmeprotesen er ikke et
permanent implantat og skal derfor udskiftes med jævne mellemrum.
Protesen (gur 1) fås med forskellige diametre og i ere længder.
Enheden er fremstillet af medicinsk silikonegummi og uoroplast.
Provox Vega-pakke
Provox Vega-pakken indeholder følgende dele:
• 1 Provox Vega-stemmeprotese lagt i SmartInserter til
engangsbrug, steril (gur 2)
• 1 Provox Brush i en størrelse, som passer til stemmeprotesen,
ikke steril
• 1 Provox Vega Behandlervejledning
• 1 Provox Vega Patientvejledning
• 1 Brugsanvisning til Provox Brush
1.3 Kontraindikationer
Der er ingen kendte kontraindikationer for brug eller
udskiftning af Provox Vega-stemmeprotese hos patienter, som
allerede anvender stemmerehabilitering med protese.
1.4 ADVARSLER
Der er risiko for, at Provox Vega-stemmeprotesen kan gå løs eller
blive skubbet ud af TE-punkturen med deraf følgende ingestion,
aspiration eller vævsskader. For yderligere information om disse
situationer, se afsnittet Bivirkninger/fejlndingnedenfor.
Gør følgende for at reducere risikoen for, at protesen går løs/
skubbes ud samt følgevirkningerne heraf:
• Vælg en protese i den rigtige størrelse. Hvis den sidder stramt
er der risiko for vævsnekrose og udskubning.
• Bed patienten søge læge øjeblikkeligt, hvis der er tegn på
vævsødem og/eller inammation/infektion.
• Hvis der anvendes laryngektomi-tube eller stomaknapper,
skal disse have en passende form, således at de ikke trykker
mod protesen eller sidder fast i protesens trachealange under
isætning og fjernelse af laryngektomi-tuben eller stomaknappen.
• Fortæl patienten, at der kun må bruges originalt Provox-
tilbehør af tilsvarende størrelse (Brush, Flush, Plug) til
vedligeholdelse, samt at alle andre typer manipulation skal
undgås.
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