Atos Provox LaryTube Manual de utilizare

LaryTube

™

IFU

MD

RT

1

REF 7637 - 7647

Figure 2

Figure 3

f

REF 7601 - 7615

d

e

ab

REF 7624 - 7631

h

c

Figure 1

g

i

3

20-40°C

68-104°F

Provox XtraFlow HME Cassette

Provox XtraMoist HME Cassette Provox TubeHolder Provox LaryClip

Figure 4

Figure 6a

abc

Figure 5

2 /250 ml (8,5 fl oz)

50-60°C

122-140°F

15 min

Figure 6b

4

2 h

35-45°C

95-113°F

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

Figure 6c Figure 6d

Figure 6g

Figure 6e Figure 6f

Figure 6h

5

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



hereunder as to the lifetime of the product delivered, which may vary with





Patents and trademarks



®

is a registered trademark owned by Atos Medical AB, Sweden.

LaryTube

™

and LaryClip

™

are trademarks of Atos Medical AB.

For information about protective rights (e.g. patents), please refer to our web

page www.atosmedical.com/patents.

6

EN  ENGLISH ........................................................................................................7

DE  DEUTSCH ................................................................................................... 14

NL  NEDERLANDS ...........................................................................................22

FR  FRANÇAIS ...................................................................................................29

IT  ITALIANO ......................................................................................................36

ES  ESPAÑOL ..................................................................................................... 43

PT  PORTUGUÊS .............................................................................................. 50

SV  SVENSKA .....................................................................................................57

DA  DANSK ........................................................................................................ 64

NO  NORSK ........................................................................................................ 71

FI SUOMI ........................................................................................................... 78

IS  ÍSLENSKA .....................................................................................................85

ET  EESTI ............................................................................................................. 92

LT  LIETUVIŲ KALBA .......................................................................................99

CS  ČESKY ......................................................................................................... 103

HU  MAGYAR ...................................................................................................113

SL  SLOVENŠČINA .........................................................................................120

SK  SLOVENČINA ...........................................................................................127

PL  POLSKI .......................................................................................................134

RO  ROMÂNĂ .................................................................................................. 141

HR  HRVATSKI ................................................................................................148

SR  SRPSKI ........................................................................................................155

EL  ΕΛΛΗΝΙΚΑ ................................................................................................162

TR  TÜRKÇE ......................................................................................................170

KA  ქართული ............................................................................................ 177

HY - ՀԱՅԵՐԵՆ .................................................................................................186

RU  PYCCK .................................................................................................194

MS  BAHASA MELAYU .................................................................................202

JA  ................................................................................................209

KO - 한국어 ..............................................................................................216

ZHTW - 繁體中文 ...............................................................................223

HE  .............................................................................................234

AR  ..............................................................................................239

ORDERING INFORMATION .........................................................................240

Contents

7

1. Descriptive information

1.1 Intended use



for vocal and pulmonary 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 tracheal or tracheostoma tissue.

1.3 Description of the device















through the voice prosthesis for voice prosthesis users. The holes are punched





Standard versions



Fenestrated versions



Ring versions





d) Tube

e) Shield (conical)

ENGLISH

8

 

g) Wings



i) Fenestration holes

1.4 WARNINGS

• DO NOT 



contamination.

• DO NOT use lubricating gels if the patient has allergies related to these

substances.

• DO ensure that the patient has been trained in the use of the device. The

patient should demonstrate the ability to understand and consistently follow



1.5 PRECAUTIONS

            

LaryTube is too wide, too narrow, too long or too short it may cause tissue

           

 



  

that is too narrow may cause the stoma to shrink.

• DO NOT



far into trachea it may obstruct breathing. The use of force during insertion

may cause tissue damage, bleeding or irritation and accidental dislodgement

of the voice prosthesis and/or XtraFlange if used.

             

Fenestration Punch. This will ensure that the holes are small and smooth.

Fenestration holes that are too large may cause dislodgement of the voice

prosthesis or XtraFlange. Fenestration holes with sharp edges may cause

formation of granulation tissue. Make sure that no silicone residues are left

in the holes or lumen of the LaryTube after fenestration.

• DO NOT

the device according to the cleaning and disinfection instructions below.

• DO NOT use a damaged device since this might cause aspiration of small

parts or cause formation of granulation tissue.

 

weaken, damage, or destroy the product and should not be used.

• Carefully monitor the tracheostoma tissue during radiation therapy. Stop

using the device if the stoma gets irritated or starts to bleed.

9

• Patients with bleeding disorders or patients on anticoagulants should not use



• Stop using the device if granulation tissue forms in the tracheostoma.

• DO NOT clean the device while inside the stoma since this could cause

tissue damage. Always remove the device from the stoma before cleaning.

2. Instructions for use

2.1 Preparation

Choosing correct size

Diameter:







Length:

and 55 mm.







CAUTION:



Preparing for insertion



damaged or opened. Do not use otherwise.

Make sure that your hands are thoroughly clean and dry before placing them







before insertion), and ensure that it is undamaged and shows no signs of tears,



a replacement.

Before insertion, rinse the device with drinking water to remove any











 ®

• SurgiLube®

• Xylocaine®/(lidocaine)

CAUTION: 

10



used at any time.





accidental detachment.

2.2 Operating instruction

Insertion (Fig. 3):

Provox LaryTube Standard and Fenestrated:





Provox LaryTube with Ring:





Make sure that the adhesive is centered properly so that the LaryTube does

not press on the sides of the stoma.



NOTE:





should be removed.

Device removal

 

component from the tube (Fig. 5).

 

NOTE:



symptoms persist.

2.3 Cleaning and disinfection

CAUTION: DO NOT clean the device while inside the stoma. This can cause

injury. Always remove the device from the stoma before cleaning.



drinking water to clean and rinse the device.

CAUTION:

 

11

 

 

 



 

 



 

 

 

CAUTION:

of disinfectant fumes can cause severe coughing and irritation of the airways.



contamination the device should be both cleaned and disinfected before use.



or if it has been in contact with a pet, someone with a respiratory infection, or

any other gross contamination.



LaryTube after use but also before use since there is an increased risk of infection



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 above and then



Protect from direct sunlight.

2.5 Device lifetime



device shows any signs of damage it shall be replaced earlier.

2.6 Disposal



when disposing of a used medical device.

2.7 Accessories

CAUTION: Use only original components. Other accessories may cause

product damage and/or malfunction.

12



 

 

           

LaryTube during showering.

           



 

and keeping the LaryTube in place.



3. Troubleshooting information

Bleeding of the stoma

Stop using the device. After the tracheostoma is healed gradually try to increase



bleeding or if the bleeding persists after removal of the device, stop using it

and consult your clinician.

Rapid shrinking of the stoma



tracheostoma, discuss with your clinician the possibility of having two devices



from your stoma and replace it immediately with a clean one. Cleaning of the

removed device can then be done after you have inserted the clean LaryTube.

Stoma enlarges during use



it is possible for you to use two devices (one with a smaller diameter and one













13

4. Additional information

4.1 Compatibility with MRI Examination

MR-Safe: This device does not contain any metallic elements and has no



4.2 Ordering information



4.3 User assistance information



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

14

1. Beschreibende Informationen

1.1 Verwendungszweck













bestimmt.

1.2 KONTRAINDIKATIONEN



• mechanisch beatmet werden (in jeglicher Form).

• 

1.3 Produktbeschreibung



















individuell gesiebt werden, sodass bei Stimmprothesenträgern Luft durch





Gebrauchsanweisung (siehe Bestellinformationen).

Standard-Ausführung

geeignet.



befestigt werden.

Ausführung Fenestrated (Gesiebte) 



befestigt werden.

DEUTSCH

15

Ausführung „with Ring“ (mit Ring)

ohne Stimmprothese geeignet.







e) Schild (konisch geformt)



g) Flügel





1.4 WARNHINWEISE

•    NICHT bei verschiedenen Patienten



Patienten bestimmt. Die Wiederverwendung bei weiteren Patienten kann



• KEINE

allergisch ist.

• SICHERSTELLEN, dass der Patient in der Anwendung des Produkts

geschult wurde. Der Patient muss in der Lage sein, die Gebrauchsanweisung



1.5 VORSICHTSMASSNAHMEN

•         



       











•  KEINE



    

      





• 





       

16







• KEINE





•     NICHT verwendet werden, da dies die

       



•       



und dürfen nicht verwendet werden.

• Das Tracheostomagewebe während einer Bestrahlung sorgfältig überwachen.

        



• 

        

wiederkehrende Blutungen verursacht.

• Das Produkt nicht weiter verwenden, wenn sich Granulationsgewebe im

Tracheostoma bildet.

• Das Produkt NICHT

    

stets aus dem Tracheostoma herausnehmen.

2. Gebrauchsanweisung

2.1 Vorbereitung

Auswahl der richtigen Größe

Durchmesser:









Länge:











17

VORSICHT:



(Abb. 3).

Vorbereitung für das Einsetzen





nicht verwenden.

Sicherstellen, dass vor dem Berühren des Tracheostomabereichs oder dem



gereinigt und trocken sind.







stets sorgfältig überprüfen und sicherstellen, dass sie unbeschädigt ist und



Beschädigungen festgestellt werden, das Produkt nicht verwenden und für









Wasser verwenden.







• ®

• SurgiLube®

• Xylocaine®/(Lidocain)

VORSICHT: 



und dürfen niemals verwendet werden.







2.2 Handhabung

Einsetzen (Abb.3):

Provox LaryTube Standard und Fenestrated (gesiebt):







18

Provox LaryTube with Ring (mit Ring):













HINWEIS:







LaryTube entfernt werden.

Entfernen des Produkts







 

HINWEIS:





2.3 Reinigung und Desinfektion

VORSICHT: 



stets aus dem Tracheostoma herausnehmen.





VORSICHT:



 







3.

       









5. 







• 

• 

• 

19

VORSICHT: Das Produkt darf erst verwendet werden, wenn es vollständig







kontaminationsgefährdeten Bereich luftgetrocknet wurde, sollte sie vor dem

















statt Trinkwasser besser steriles Wasser verwenden.

VORSICHT: 





2.4 Lagerungshinweise







2.5 Nutzungsdauer des Produkts



verwendet werden. Weist das Produkt allerdings Schäden auf, sollte es bereits

früher ausgetauscht werden.

2.6 Entsorgung







2.7 Zubehör

VORSICHT:







•         

Feuchtigkeitsaustauscher)].

•         

Tracheostomas.

20

•         



• 





• 





beachten.

3. Informationen zur Problemlösung

Tracheostomablutung











Schnelles Schrumpfen des Tracheostomas













Tracheostomavergrößerung während des Gebrauchs















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

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