Atos PROVOX LaryButton Instrucțiuni de utilizare

™

IFU

MD

RT

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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