2. Atos
  3. Provox LaryTube

Atos Provox LaryTube Používateľská príručka

  • Dobrý deň! Prečítal som si návod na použitie pre Provox LaryTube a som pripravený odpovedať na vaše otázky. Návod popisuje tri modely zariadenia, ich použitie, čistenie, dezinfekciu a riešenie problémov. Neváhajte sa opýtať na čokoľvek, čo vás zaujíma!
  • Ako vybrať správnu veľkosť Provox LaryTube?
    Ako sa čistí a dezinfikuje Provox LaryTube?
    Ako dlho sa dá Provox LaryTube používať?
    Čo robiť pri krvácaní zo stomy?
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










/