Atos Medical PROVOX LaryTube Standard User manual
LaryTube
™
IFU
MD
RT
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.
Lar yTube
™
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
Manufacturer; Hersteller; Fabrikant; Fabricant; Produttore;
Fabricante; Fabricante; Tillverkare; Producent; Produsent;
მწარმოებელი;
dusen; Pengilang; 製造業者; 제조사; 製造商; 制造商;
ןרציה;ןרציה;
Date of manufacture; Herstellungsdatum; Productiedatum; Date de
fabrico; Tillverkningsdatum; Fremstillingsdato; Produksjonsdato
;Valmistuspäivä; Framleiðsludagsetning; Valmistamise kuupäev;
წარმოების
თარიღი;
製造日;
제조일자; 製造日期; 制造日期; רוציי ךיראת;רוציי ךיראת;
dade; Används senast: Anvendes inden; Brukes innen; Viimeinen
ვარგისია;
7
שומישל ןורחא ךיראת;שומישל ןורחא ךיראת;
tanggal; Tarikh guna sebelum; 使用期限; 사용 기한; 使用截止日
期;使用截止日期;
Batch code; Chargencode; Partijnummer; Code de lot; Codice lotto;
Eränumero; Lotunúmer; Partii kood; Partijas kods; Partijos kodas;
Parti kodu; სერიის კოდი;
バッチコード;
배치 코드; 批次代碼; 批号; הווצא דוק;הווצא דוק;
Referensnummer; Produktreferencenummer; Produktreferansenum
mer; Artikkelinumero; Tilvísunarnúmer vöru; Toote viitenumber;
პროდუქტის საკონტროლო
ნომერი;
製品参照番号; 제품 참조 번호; 產品參
考號; 产品参考编号; רצומה לש ןיכומיס רפסמ;רצומה לש ןיכומיס רפסמ;
8
არასტერილური;
steril; Tidak steril; 非滅菌; 무균 아님; 未滅菌; 非无菌;
רקועמ אל;רקועמ אל;
Keep away from sunlight and keep dry; Vor Sonnenlicht und
bewaren; Maintenir à l’abri de la lumière directe du soleil et de
solar e da chuva; Håll borta från solljus och håll torr; Holdes bort
fra sollys og holdes tør; Unngå direkte sollys, holdes tørr; Säi
შეინახეთ
მზისგან დაცულ ადგილას და მშრალ მდგომარეობაში;
9
שבי םוקמב ןסחאלו שמשה רואמ קיחרהל שי;שבי םוקמב ןסחאלו שמשה רואמ קיחרהל שי;
dan simpan di tempat yang kering; Jauhkan dari cahaya matahari
dan pastikan sentiasa kering; 直射日光および湿気禁止;
직사광선이 닿지 않게 하고 건조한 상태로 유지하십시오;
避免日照並保持乾燥; 避免日照和保持干燥。;
ture di stoccaggio; Límite de temperatura de almacenamiento;
შენახვის ტემპერატურის
ლიმიტი;
suhu penyimpanan; Had suhu simpanan; 保管温度制限 ; 보관 온도
제한; 儲存溫度限制; 储存温度限制; ןוסחא תרוטרפמט תלבגהןוסחא תרוטרפמט תלבגה
10
RT
MAX
MIN
Store at room temperature. Temporary deviations within the
lagern. Temperaturschwankungen innerhalb des Temperaturbereichs
Conservare a temperatura ambiente. Sono consentiti scostamenti
temperatura ambiente. Se permiten desviaciones temporales dentro
Midlertidige avvik innenfor temperaturområdet (maks.–min.) er
11
חווט ךותב תוינמז תויטס תורתומ .רדחה תרוטרפמטב ןסחאל שי חווט ךותב תוינמז תויטס תורתומ .רדחה תרוטרפמטב ןסחאל שי
.)םומינימ-םומיסקמ( הרוטרפמטה.)םומינימ-םומיסקמ( הרוטרפמטה
) .
.( -
შეინახეთ
ოთახის ტემპერატურაზე. დროებითი გადახრები
ტემპერატურის ფარგლებში )მაქს.-მინ.( დასაშვებია;
kan: 室温で保管。温度範囲（最大～最小）内の温度逸脱は許
容。; 실온에서 보관하십시오. 온도 범위내에서의 일시적인 편
차)최대-최소(는 허용됩니다; 室溫儲存。允許在溫度範圍內（
上限至下限）的溫度差異。; 室温下存放。允许温度范围内（
最高-最低）的暂时偏差。;
12
tion; Forsigtig, se brugsanvisning; Forsiktig, se bruksanvisningen;
Varoitus, katso käyttöohjeet; Varúð, lesið notkunarleiðbeiningarnar;
inceleyin; გაფრთხილება, მოითხოვეთ გამოყენების
ინსტრუქცია;
penggunaan; 注意、取扱説明書を参照; 주의, 사용 지침을 참조
하십시오; 注意事項，參閱使用說明; 小心，参阅使用说明书;
שומישה תוארוהב ןייעל שי ,תוריהז; שומישה תוארוהב ןייעל שי ,תוריהז;
13
co; Medicinteknisk produkt; Medicinsk udstyr; Medisinsk utstyr;
სამედიცინო მოწყობილობა;
batan; 医療機器; 의료 장치; 醫療裝置; 医疗器械;
יאופר ןקתה;יאופר ןקתה;
MD
IFU
გამოყენების ინსტრუქცია;
gunaan; Arahan penggunaan; 取扱説明書; 사용 지침; 使用說明;
使用说明书; שומיש תוארוה;שומיש תוארוה;
14
EN ENGLISH ..................................................................................................... 15
DE DEUTSCH ...................................................................................................22
NL NEDERLANDS........................................................................................... 30
FR FRANÇAIS................................................................................................... 37
IT ITALIANO...................................................................................................... 44
ES ESPAÑOL..................................................................................................... 51
PT PORTUGUÊS.............................................................................................. 58
SV SVENSKA..................................................................................................... 65
DA DANSK........................................................................................................ 72
NO NORSK........................................................................................................ 79
FI SUOMI........................................................................................................... 86
IS ÍSLENSKA .....................................................................................................93
ET EESTI...........................................................................................................100
LT LIETUVIŲ KALBA.....................................................................................107
CS ČESKY.........................................................................................................114
HU MAGYAR...................................................................................................121
SL SLOVENŠČINA.........................................................................................128
SK SLOVENČINA...........................................................................................135
PL POLSKI .......................................................................................................142
RO ROMÂNĂ..................................................................................................149
HR HRVATSKI ................................................................................................156
SR SRPSKI........................................................................................................163
EL ΕΛΛΗΝΙΚΑ ................................................................................................170
TR TÜRKÇE......................................................................................................178
KA - ᲥᲥᲥᲥᲥᲥᲥ ..................................................................................185
HY - ՀԱՅԵՐԵՆ.................................................................................................194
RU PYCCK.................................................................................................202
MS BAHASA MELAYU.................................................................................210
JA ................................................................................................217
KO - 한국어..............................................................................................224
ZHTW - 繁體中文...............................................................................231
HE .............................................................................................242
AR ..............................................................................................247
ORDERING INFORMATION.........................................................................248
Contents
15
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
There are 3 models: Standard, Fenestrated and with Ring (Fig. 1).
The Standard model and the Ring version can be fenestrated so that air can go
through the voice prosthesis for voice prosthesis users. The holes are punched
Standard versions (Fig. 1a) – made for use with or without a voice prosthesis.
Fenestrated versions (Fig. 1b) – For voice prosthesis users.
Ring versions (Fig. 1c) – made for use with or without a voice prosthesis.
d) Tube
e) Shield (conical)
ENGLISH
16
f) HME and Accessory Holder
h) Ring for adhesive connection
i) Fenestration holes
1.4 WARNINGS
• DO NOT
intended for single patient use only. Reuse in another patient may cause cross
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
Fenestration Punch. This will ensure that the holes are small and smooth.
Fenestration holes that are too large may cause dislodgement of the voice
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.
17
• 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
disinfectant residues (Fig. 2). Make sure that you only insert clean devices.
• KY Jelly®
• SurgiLube®
®/(lidocaine)
CAUTION:
18
Vaseline) may weaken, damage, or destroy the product and should not be
used at any time.
Make sure that you do not lubricate the HME Holder, HME Cassette or
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:
injury. Always remove the device from the stoma before cleaning.
drinking water to clean and rinse the device.
CAUTION:
19
the following methods:
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
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:
product damage and/or malfunction.
20
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
alternative options to attach the HME Cassette with your clinician so that you
can continue HME Cassette use during the night.
This manual suits for next models
2
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