2. Atos
  3. PROVOX LaryButton

Atos PROVOX LaryButton Kasutusjuhend

™
IFU
MD
RT
1
1
2
3
de
a
b
c
3
3a
3b
b-1
a-1
a-2
4
b-2
b-3
b-4
5
4c
4b
4a
2 /250 ml (8,5 fl oz)
50-60° C
122-140° F
15 min
20-40°C
68-104°F
5a 5b
6
2 h
70 % Ethanol 10 min
/(or)
70 % Isopropylalcohol 10 min
/(or)
3 % Hydrogenperoxide 60 min
35-45°C
95-113°F
35-45°C
95-113°F
5c 5d
5e 5f
5g
7
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


product delivered, which may vary with individual use and


particular purpose.
Patents and trademarks

®
is a registered trademark owned by Atos Medical AB,
Sweden. LaryButton™ is a trademark of Atos Medical AB.
For information about protective rights (e.g. patents), please
refer to the webpage www.atosmedical.com/patents
8
EN - ENGLISH ..........................................................................................9
DE - DEUTSCH ..................................................................................... 19
NL - NEDERLANDS ............................................................................. 30
FR - FRANÇAIS ..................................................................................... 41
IT - ITALIANO ........................................................................................ 51
ES - ESPAÑOL ....................................................................................... 62
PT - PORTUGUÊS ................................................................................ 73
SV - SVENSKA ....................................................................................... 84
DA - DANSK .......................................................................................... 94
NO - NORSK ........................................................................................104
FI - SUOMI ...........................................................................................114
IS - ÍSLENSKA .....................................................................................124
ET - EESTI ............................................................................................. 134
LT - LIETUVIŲ K. ................................................................................. 144
CS - ČESKY ...........................................................................................154
HU - MAGYAR .....................................................................................164
SK - SLOVENČINA ............................................................................. 174
SL - SLOVENŠČINA ........................................................................... 184
PL - POLSKI .........................................................................................194
RO - ROMÂNĂ ....................................................................................205
HR - HRVATSKI ...................................................................................216
SR - SRPSKI .......................................................................................... 226
EL - ΕΛΛΗΝΙΚΑ ..................................................................................236
TR - TÜRKÇE ........................................................................................ 248
HY -  ................................................................................258
RU - PYCCKИЙ ...................................................................................271
MS - BAHASA MELAYU ................................................................... 283
JA - 日本語 .......................................................................................... 294
KO - 󼨫󺈼󻪃 .......................................................................................... 306
ZH-TW - 󶍘󹠔󰶦󳛓 ...........................................................................217
HE - ..................................................................................... 334
AR - ....................................................................................... 342
Contents
9
1. Descriptive information
1.1 Intended use


rehabilitation after total laryngectomy.
For patients with a shrinking tracheostoma it is also used
to maintain the tracheostoma for breathing.

1.2 CONTRAINDICATIONS

• are under any form of mechanical ventilation.
• have damaged tracheostoma tissue.
1.3 Description of the device

made of medical grade silicone rubber. The purpose of the





a) Retention Collar
b) Shaft
c) Shield (conical)

e) Wings
ENGLISH
10
1.4 WARNINGS
•         
      
cause tissue damage or irritation. If it is too long it may also
cause dislodgement of the voice prosthesis or XtraFlange.



is too long.
• 

pushed too far into trachea it may obstruct breathing.
• DO NOT       

diameter and/or the mechanical stability of the product. This
may result in the LaryButton being pushed into the trachea,

also cause irritation and/or bleeding.
• DO NOT fenestrate the LaryButton as the fenestration
might cause dislodgement of the voice prosthesis or
XtraFlange.
• DO NOT
The device is intended for single patient use only. Reuse
between patients may cause cross contamination.
• 
to the instructions below.
DO NOT use force and do not fold the part of the

If the product is pushed too far into trachea it may obstruct
breathing and the use of force during insertion may cause
bleeding.
• If used, DO NOT push the tip of the hemostats or forceps

tip is protruding from the button during insertion, the tissue
11
of the trachea could be harmed and/or the voice prosthesis
could become dislodged and subsequently be aspirated or
ingested.
• DO NOT use lubricating gels if the patient has allergies
related to these substances.
• Always remove the device from the stoma before cleaning.
DO NOT at any time attempt to clean the device while
inside the stoma since this could cause tissue damage and
dislodgement of voice prosthesis.
• Make sure that the patient has been trained in the use of
the device, and has demonstrated the ability to understand
and consistently follow the Instructions for Use without
clinician supervision.
1.5 PRECAUTIONS
• DO NOT
Clean and disinfect the device according to the cleaning and
disinfection instructions below.
• DO NOT use toothed or sharp instruments at any time
during insertion since they could damage the LaryButton
and cause tissue damage.
• DO NOT use a damaged device since this might cause
aspiration of small parts or cause formation of granulation
tissue.
•      
(e.g., Vaseline) may weaken, damage, or destroy the product
and should not be used at any time.
• Carefully monitor the tracheostoma tissue during radiation
therapy and stop using the device if the stoma gets irritated
or starts to bleed.
• Patients with bleeding disorders or patients on anticoagulants

• Stop using the device if granulation tissue forms in the
tracheostoma.
12
2. Instructions for use
2.1 Preparation
Choosing correct size
Diameter:

the diameter of the tracheostoma entrance. This is especially


LaryButton accordingly. In irregularly shaped tracheostomas,


out or air may escape when speaking. Selection of a too wide
LaryButton may irritate or damage the tracheostoma.
Length:


device is too short it may fall out of the tracheostoma.




CAUTION: 



is situated uniformly around the tracheostoma.
13
Preparing for insertion

the package is not damaged or opened. Do not use otherwise.
Make sure that your hands are thoroughly clean and dry
before placing them in the area of the stoma or handling the




undamaged and shows no signs of tears, cracks, or crusts. If
you detect any damage, do not use the product, and obtain a
replacement.
Before insertion, rinse the device with drinking water to

only insert clean devices. In a hospital setting it is better to
use sterile water rather than drinking water.
If needed, lightly lubricate the Retention Collar of the device


• KY Jelly®
• SurgiLube®
• Xylocaine®/(lidocaine)
CAUTION:
lubricants (e.g., Vaseline) may weaken damage or destroy the
product and should not be used at any time.


LaryButton, as this may lead to accidental detachment.
14
2.2 Operating instruction
Insertion (Fig. 3):
Alternative 3a:
         

Insert the Retention Collar into the stoma and release it

Alternative 3b:

Use a pair of blunt forceps or a lockable blunt hemostat

CAUTION: DO NOT push the tip of the hemostats or
     
instrument tip is protruding from the button during insertion,
the tissue of the trachea could be harmed and/or the voice
prosthesis could become dislodged and subsequently be
aspirated or ingested.

4. 



NOTE:
after inserting the LaryButton and when touching the device to
speak. This usually diminishes when the user gets used to the
device. If discomfort occurs the LaryButton should be removed.
15
Device removal
    

(Fig. 4a).

a turn) to allow the Retention Collar to collapse thereby
reducing its width (Fig. 4b).
Remove the device by gently tilting it out of the stoma (Fig. 4c).
Alternatively, the device can be removed by pushing with a

NOTE: The insertion or removal procedures may occasionally
cause some slight bleeding, irritation or coughing. Inform your
clinician if the bleeding persists.
2.3 Cleaning and disinfection
CAUTION: Always remove the device from the stoma before
cleaning.
DO NOT at any time attempt to clean the device while inside
the stoma since this could cause injury.


Do not use any water other than drinking water to clean
and rinse the device.
CAUTION:
cleaning water.


• 
• 
• 
16
CAUTION: DO NOT use the device until it is completely dry

coughing and irritation of the airways.

area with a risk of contamination the device should be both
cleaned and disinfected before use. A risk of contamination

it has been in contact with a pet, someone with a respiratory
infection, or any other gross contamination.


is an increased risk of infection and contamination. In a hospital
it is better to use sterile water for cleaning and rinsing, rather
than drinking water.
CAUTION: DO NOT clean or disinfect by any other method
than described above as this might cause product damage and
patient injury.
2.4 Storage instructions
When not in use, clean and disinfect the device as described

container at room temperature. Protect from direct sunlight.
2.5 Device lifetime


be replaced earlier.
2.6 Disposal
Always follow medical practice and national requirements

17
2.7 Accessories
CAUTION: Use only original components. Other accessories
may cause product damage and/or malfunction.


• 
•       
stoma occlusion.
•         
entering the LaryButton during showering.


from falling out of the stoma.
3. Troubleshooting information
Bleeding of the stoma
Stop using the device. After the tracheostoma is healed try
gradually increasing the duration of using the device. If even
short periods of use cause bleeding or if the bleeding persists
after removing the device, stop using it and consult your
clinician.
Rapid shrinking of the stoma

shrinking tracheostoma, discuss with your clinician the


and replace it immediately with a clean one. Cleaning of the
removed device can then be done afterwards.
18
Stoma enlarges during use
If your tracheostoma enlarges after using the device for some
hours, ask your clinician if it is possible for you to use two
devices (one smaller and one larger diameter). This allows you


necessary to discontinue use of the button during the night, so
that the tracheostoma can shrink. In that case, discuss alternative


4. Additional information
4.1 Compatibility with MRI Examination
MR-Safe: This device does not contain any metallic elements

4.2 User assistance information
For additional help or information please see back cover of
this Instructions for Use for contact information.
5. Reporting
Please note that any serious incident that has occurred in
relation to the device shall be reported to the manufacturer
and the national authority of the country in which the user
and/or patient resides.
19
1. Beschreibende Informationen
1.1 Verwendungszweck



totalen Laryngektomie.

Tracheostoma Anwendung, um das Tracheostoma für die



1.2 KONTRAINDIKATIONEN


• mechanisch beatmet werden (in jeglicher Form).
• Schäden am Tracheostomagewebe aufweisen.
1.3 Produktbeschreibung









b) Schaft
DEUTSCH
20
c) Schild (konisch geformt)

e) Flügel
1.4 WARNHINWEISE
•    
         
   
        
oder des XtraFlange führen. Darüber hinaus kann, wenn
        
        
   
Stimmprothese ausüben.
• 


• NICHT
      
     
mechanische Stabilität des Produkts verändert. Als Folge

      
     
Blutungen verursachen.
•    NICHT sieben, da die Siebung
      

•    NICHT bei verschiedenen
      
      
Wiederverwendung bei weiteren Patienten kann eine

•       
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