Atos Medical Provox Dilator 17 User manual

Dilator
MD
RT
IFU

1.2
1.1
1.3
1.4
1.6
1.5
Fig. 3
Provox Dilator 17/20
REF 7122, 7123
Fig. 5 Fig. 6
Fig. 7 Fig. 8
Fig. 1
Fig. 4
Fig. 2

3
2 /250 ml (8,5 fl oz)
15 s
70 % Ethanol
or
70 % Isopropylalcohol
or
3 % Hydrogenperoxide
10 min
10 min
60 min
50°-100° C
122°-212° F
2 /250 ml (8,5 fl oz)
15 s
70 % Ethanol
or
70 % Isopropylalcohol
or
3 % Hydrogenperoxide
10 min
10 min
60 min
50°-100° C
122°-212° F
2 /250 ml (8,5 fl oz)
15 s
70 % Ethanol
or
70 % Isopropylalcohol
or
3 % Hydrogenperoxide
10 min
10 min
60 min
50°-100° C
122°-212° F
Fig. 9
Fig. 12 Fig. 13
2 /250 ml (8,5 fl oz)
15 s
70 % Ethanol
or
70 % Isopropylalcohol
or
3 % Hydrogenperoxide
10 min
10 min
60 min
50°-100° C
122°-212° F
Fig. 14
2 /250 ml (8,5 fl oz)
15 s
70 % Ethanol
or
70 % Isopropylalcohol
or
3 % Hydrogenperoxide
10 min
10 min
60 min
50°-100° C
122°-212° F
Fig. 10 Fig. 11

4
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
Atos Medical offers no warranty - neither expressed
nor implied - to the purchaser hereunder as to the
lifetime of the product delivered, which may vary
with individual use and biological conditions.
Furthermore, Atos Medical offers no warranty of
merchantability or tness of the product for any
particular purpose.
Patents and trademarks
Provox®is a registered trademark owned by Atos
Medical AB, Sweden.
For information about protective rights (e.g. patents),
please refer to our web page
www.atosmedical.com/patents.

5
Manufacturer; Hersteller; Fabrikant; Fabricant;
Produttore; Fabricante; Fabricante; Tillverkare; Pro-
ducent; Produsent; Valmistaja; Framleiðandi; Tootja;
Ražotājs; Gamintojas; Výrobce; Gyártó; Výrobca;
Proizvajalec; Producent; Producător; Proizvođač;
Proizvođač; Κατασκευαστής; Производител;
Üretici; მწარმოებელი; Արտադրող; İstehsalçı;
Производитель; Produsen; Pengilang; 製造業者;
제조사; 製造商; 制造商; ןרציה;ןרציה;  
Date of manufacture; Herstellungsdatum; Productieda-
tum; Date de fabrication; Data di fabbricazione; Fecha
de fabricación; Data de fabrico; Tillverkningsdatum;
Fremstillingsdato; Produksjonsdato;Valmistuspäi
vä; Framleiðsludagsetning; Valmistamise kuupäev;
Ražošanas datums; Pagaminimo data; Datum výroby;
Gyártás időpontja; Dátum výroby; Datum proizvodnje;
Data produkcji; Data fabricației; Datum proizvodnje;
Datum proizvodnje; Ημερομηνία κατασκευής; Дата на
производство; Üretim tarihi; წარმოების თარიღი;
Արտադրման ամսաթիվ; İstehsal tarixi; Дата
изготовления; Tanggal produksi; Tarikh pembuatan; 製
造日; 제조일자; 製造日期; 制造日期;
רוציי ךיראת;רוציי ךיראת;  
Use-by date; Verfallsdatum; Houdbaarheidsdatum;
Date limite d’utilisation; Data di scadenza; Fecha de
caducidad; Data de validade; Används senast: Anvendes
inden; Brukes innen; Viimeinen käyttöpäivä; Síðasti
notkunardagur; Kõlblik kuni; Derīguma termiņš; Nau-
doti iki; Datum expirace; Felhasználhatóság dátuma;
Dátum najneskoršej spotreby; Rok uporabnosti; Data
ważności; Data expirării; Rok uporabe; Rok upotrebe;
Ημερομηνία λήξης; Срок на годност; Son kullanım
tarihi; ვარგისია; Պիտանելիության ժամկետ; Son
istifadə tarixi; Срок годности; Gunakan sebelum tang-
gal; Tarikh guna sebelum; 使用期限; 사용 기한; 使用
截止日期; 使用截止日期;
שומישל ןורחא ךיראת;שומישל ןורחא ךיראת;   

6
Batch code; Chargencode; Partijnummer; Code de lot;
Codice lotto; Código de lote; Código do lote; Batchkod;
Batchkode; Batchkode; Eränumero; Lotunúmer; Partii
kood; Partijas kods; Partijos kodas; Kód šarže; Sarzs
kód; Kód šarže; Številka serije; Kod partii; Codul lotu-
lui; Šifra serije; Šifra serije; Κωδικός παρτίδας; Код на
партида; Parti kodu; სერიის კოდი; Խմբաքանակի
կոդ; Partiya kodu; Код партии; Kode batch; Kod
kelompok; バッチコード; 배치 코드;
批次代碼; 批号; הווצא דוק;הווצא דוק;  
Product reference number; Produktreferenznummer;
Referentienummer product; Numéro de référence du
produit; Numero riferimento prodotto; Número de
referencia del producto; Referência do produto; Refer-
ensnummer; Produktreferencenummer; Produktrefer-
ansenummer; Artikkelinumero; Tilvísunarnúmer vöru;
Toote viitenumber; Produkta atsauces numurs; Gaminio
katalogo numeris; Referenční číslo produktu; Termék
referenciaszáma; Referenčné číslo produktu; Referenčna
številka izdelka; Numer katalogowy produktu; Numărul
de referință al produsului; Referentni broj proiz-
voda; Referentni broj proizvoda; Αριθμός αναφοράς
προϊόντος; Референтен номер на продукт; Ürün
referans numarası; პროდუქტის საკონტროლო
ნომერი; Արտադրանքի տեղեկատու համարը;
Məhsula istinad nömrəsi; Справочный номер изделия;
Nomor referensi produk; Nombor rujukan produk; 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;   
Keep away from sunlight and keep dry; Vor Son-
nenlicht und Feuchtigkeit schützen; Niet blootstellen
aan zonlicht, droog bewaren; Maintenir à l’abri de
la lumière directe du soleil et de l’humidité; Tenere
all’asciutto e al riparo dalla luce del sole; Mantener
seco y alejado de la luz solar; Manter afastado da luz

7
solar e da chuva; Håll borta från solljus och håll torr;
Holdes bort fra sollys og holdes tør; Unngå direkte
sollys, holdes tørr; Säilytettävä kuivassa paikassa
suojassa auringonvalolta; Geymið fjarri sólarljósi og
haldið þurru; Hoida kuivas ja eemal päikesevalgus-
est; Sargāt no saules stariem un mitruma; Saugoti nuo
saulės šviesos ir laikyti sausai; Chraňte před slunečním
zářením a udržujte v suchu; Tartsa a napfénytől távol,
és tartsa szárazon; Chráňte pred slnečným žiarením
a uchovávajte v suchu; Shranjujte na suhem in ne
izpostavljajte sončni svetlobi; Chronić przed światłem
słonecznym i przechowywać w suchym miejscu; A se
feri de lumina soarelui și a se menține uscat; Čuvajte
na suhom mjestu i podalje od Sunčeve svjetlosti;
Držati dalje od sunčeve svetlosti i čuvati na suvom;
Φυλάσσετε μακριά από το ηλιακό φως και διατηρείτε
τη συσκευή στεγνή; Дръжте далече от слънчева
светлина и съхранявайте на сухо място; Güneş
ışığından uzakta ve kuru tutun; შეინახეთ მზისგან
დაცულ ადგილას და მშრალ მდგომარეობაში;
Հեռու պահեք արևի ճառագայթներից և պահեք
չոր տեղում; Gün işığından uzaqda və quru saxlayın;
Берегите от воздействия прямых солнечных лучей
и влаги; Hindarkan dari sinar matahari 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; 직
사광선이 닿지 않게 하고 건조한 상태로 유지하십시
오; 避免日照並保持乾燥; 避免日照和保持干燥。;
שבי םוקמב ןסחאלו שמשה רואמ קיחרהל שישבי םוקמב ןסחאלו שמשה רואמ קיחרהל שי
        
Non-sterile; Unsteril; Niet steriel; Non stérile; Non
sterile; No estéril; Não estéril; Osteril; Ikke-steril;
Usteril; Steriloimaton; Ósæft; Mittesteriilne; Nesterils;
Nesterilu; Nesterilní; Nem steril; Nesterilné; Nest-
erilno; Produkt niejałowy; Produs nesteril; Nesterilno;
Nije sterilno; Μη αποστειρωμένο; Нестерилно; Steril
değildir; არასტერილური; Ոչ ստերիլ; Qeyri-steril;
Нестерильно; Tidak steril; Tidak steril; 非滅菌;
무균 아님; 未滅菌; 非无菌; רקועמ אל;רקועמ אל;  

8
ןוסחא תרוטרפמט תלבגה;ןוסחא תרוטרפמט תלבגה;    
RT
MAX
MIN
Store at room temperature. Temporary deviations within
the temperature range (max-min) are allowed; Bei Zim-
mertemperatur lagern. Temperaturschwankungen inner-
halb des Temperaturbereichs (min.–max.) sind zulässig;
Bij kamertemperatuur bewaren. Tijdelijke afwijkingen
van de temperatuur binnen de marge (min-max) zijn
toegestaan; Stocker à température ambiante Des écarts
temporaires dans la plage de température ambiante
(max-min) sont autorisés; Conservare a temperatura
ambiente. Sono consentiti scostamenti temporanei
entro i limiti di temperatura (max-min); Almacenar
a temperatura ambiente. Se permiten desviaciones
temporales dentro del rango de temperatura (máx.-
mín.); Guardar à temperatura ambiente. São permitidos
desvios temporários dentro do intervalo das temperatu-
ras (máx-min); Förvara i rumstemperatur. Tillfälliga av-
Storage temperature limit; Lagertemperaturgrenze;
Maximale bewaartemperatuur; Limite de température
de stockage; Temperature di stoccaggio; Límite de
temperatura de almacenamiento; Limite da temperatura
de armazenamento; Temperaturgränser för förvaring;
Opbevaringstemperaturbegrænsning; Oppbevaringstem-
peraturgrense; Säilytyslämpötilan raja; Takmarkanir á
hitastigi við geymslu; Säilitustemperatuuri piirmäär;
Uzglabāšanas temperatūras ierobežojums; Laikymo
temperatūros riba; Maximální skladovací teplota;
Tárolási hőmérsékletkorlát; Limit skladovacej teploty;
Omejitve temperature za shranjevanje; Temperatura
przechowywania; Limita temperaturii de depozitare;
Ograničenje temperature skladištenja; Ograničenje
temperature skladištenja; Όρια θερμοκρασίας
αποθήκευσης; Граници на температурата на
съхранение; Saklama sıcaklığı sınırı; შენახვის
ტემპერატურის ლიმიტი; Պահպանման
ջերմաստիճանի սահմանները; Saxlama temperaturu
həddi; Ограничения температуры хранения; Batas
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;

9
vikelser inom temperaturområdet (max–min.) är tillåtna;
Opbevar ved rumtemperatur. Midlertidige afvigelser i
temperaturintervallet (maks-min) er tilladt; Oppbevares
i romtemperatur. Midlertidige avvik innenfor tempera-
turområdet (maks.–min.) er tillatt; Säilytä huoneenläm-
mössä. Väliaikainen poikkeama lämpötila-alueella
(suurin-pienin) on sallittu; Geymið við stofuhita.
Tímabundin frávik innan hitasviðs (lágm.–hám.) eru
leyfð; Hoida toatemperatuuril. Ajutised nihked tem-
peratuurivahemikus (max–min) on lubatud; Uzglabāt
istabas temperatūrā. Ir pieļaujamas īslaicīgas novirzes
temperatūras diapazona ietvaros (min.–maks.); Laikyti
kambario temperatūroje. Leidžiami laikini nuokrypiai,
neviršijantys temperatūros intervalo (didž.–maž.);
Skladujte při pokojové teplotě. Dočasné odchylky
od teplotního rozsahu (max–min) jsou povoleny;
Tárolja szobahőmérsékleten. Az átmeneti ingadozás a
hőmérséklet-tartományon belül (max.–min.) enge-
délyezett; Uchovávajte pri izbovej teplote. Dočasné
odchýlky v rámci teplotného rozsahu (max – min) sú
povolené; Shranjujte pri sobni temperaturi. Do-
voljena so začasna odstopanja znotraj temperaturnega
razpona (najv.–najm.); Przechowywać w temperaturze
pokojowej. Dopuszczalne są przejściowe odchylenia
w obrębie zakresu temperatury (maks. — min.); A se
păstra la temperatura camerei. Sunt permise abateri
temporare în intervalul de temperatură (min.–max.);
Skladištite pri sobnoj temperaturi. Dopuštena su privre-
mena odstupanja unutar raspona temperature (maks.
– min.); Čuvati na sobnoj temperaturi. Dozvoljena su
privremena odstupanja unutar temperaturnog opsega
(maks.–min.); Φυλάσσετε σε θερμοκρασία δωματίου.
Επιτρέπονται παροδικές αποκλίσεις εντός του εύρους
θερμοκρασίας (μέγιστη-ελάχιστη); Съхранявайте
на стайна температура. Временните отклонения
в температурните диапазони (макс. – мин.) са
разрешени; Oda sıcaklığında saklayın. Sıcaklık aralığı
(maksimum-minimum) içerisinde geçici sapmalara
izin verilir; შეინახეთ ოთახის ტემპერატურაზე.
დროებითი გადახრები ტემპერატურის
ფარგლებში (მაქს.-მინ.) დასაშვებია; Պահել
սենյակային ջերմաստիճանում: Թույլատրվում են
ժամանակավոր տատանումներ ջերմաստիճանի

10
תוינמז תויטס תורתומ .רדחה תרוטרפמטב ןסחאל שי תוינמז תויטס תורתומ .רדחה תרוטרפמטב ןסחאל שי
.(םומינימ-םומיסקמ) הרוטרפמטה חווט ךותב.(םומינימ-םומיסקמ) הרוטרפמטה חווט ךותב
      .     
.( - ) 
ընդգրկույթում (առավելագույնից նվազագույն);
Otaq temperaturunda saxlayın. Maksimum və mini-
mum temperatur aralığında müvəqqəti yayınmalara
icazə verilir; Храните при комнатной температуре.
Допускаются временные отклонения интервала
температур (макс.-мин.); Simpan pada suhu ruang. De-
viasi sementara dalam rentang suhu (maks-min) diizin-
kan; Simpan pada suhu bilik. Penyimpangan sementara
dalam julat suhu (maks-min) adalah dibenarkan: 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 편차(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。;
Caution, consult instructions for use; Vorsicht, Ge-
brauchsanweisung beachten; Let op: Raadpleeg de
gebruiksaanwijzingen; Mise en garde, consulter le
mode d’emploi; Attenzione, consultare le istruzioni
per l’uso; Precaución, consultar instrucciones de uso;
Cuidado, consultar as instruções de utilização; Varning,
läs instruktion; Forsigtig, se brugsanvisning; Forsiktig,
se bruksanvisningen; Varoitus, katso käyttöohjeet;
Varúð, lesið notkunarleiðbeiningarnar; Ettevaatust,
tutvuge kasutusjuhendiga; Uzmanību! Izlasiet lietošanas
norādījumus; Dėmesio, skaityti naudojimo instrukciją;
Upozornění, viz návod k použití; Figyelem, tájékozód-
jon a használati útmutatóból; Pozor, riaďte sa návodom
na použitie; Pozor; glejte navodila za uporabo; Uwaga,
należy zapoznać się z instrukcją obsługi; Atenție!
Consultați instrucțiunile de utilizare; Pozor: proučite
upute za upotrebu; Oprez, konsultovati uputstvo za
upotrebu; Προσοχή, συμβουλευτείτε τις οδηγίες
χρήσης; Внимание, консултирайте се с инструкциите
за употреба; Dikkat, kullanmadan önce talimatları ince-
leyin; გაფრთხილება, მოითხოვეთ გამოყენების

11
שומישה תוארוהב ןייעל שי ,תוריהז שומישה תוארוהב ןייעל שי ,תוריהז
   
Medical Device; Medizinprodukt Medisch hulpmid-
del; Dispositif médical; Dispositivo medico; Producto
sanitario; Dispositivo médico; Medicinteknisk produkt;
Medicinsk udstyr; Medisinsk utstyr; Lääkinnällinen
laite; Lækningatæki; Meditsiiniseade; Medicīniska
ierīce; Medicinos priemonė; Zdravotnický prostředek;
Orvostechnikai eszköz; Zdravotnícka pomôcka;
Medicinski pripomoček; Wyrób medyczny; Dispozitiv
medical; Medicinski proizvod; Медицинско средство;
Іατροτεχνολογικό προϊόν; Медицинскоизделие; Tıbbi
cihaz; სამედიცინო მოწყობილობა; Բժշկական
սարք; Tibbi Avadanlıq; Медицинское изделие; Perala-
tan Medis; Peranti Perubatan; 医療機器; 의료 장치;
醫療裝置; 医疗器械; יאופר ןקתה;יאופר ןקתה;  
MD
ინსტრუქცია; Ուշադրություն, հետևեք
օգտագործման հրահանգներին; Xəbərdarlıq, istifadə
qaydalarını oxuyun; Предостережение, обратитесь к
инструкциям по применению; Perhatian, baca petun-
juk penggunaan; Berhati-hati, rujuk arahan penggunaan;
注意、取扱説明書を参照; 주의, 사용 지침을 참조하
십시오; 注意事項，參閱使用說明;
小心，参阅使用说明书;
IFU
Instructions for use; Gebrauchsanweisung; Ge-
bruiksaanwijzing; Mode d’emploi; Istruzioni per
l’uso; Instrucciones de uso; Instruções de utilização;
Bruksanvisning; Brugsanvisning; Bruksanvisning;
Käyttöohjeet; Notkunarleiðbeiningar; Kasutusjuhend;
Lietošanas norādījumi; Naudojimo instrukcija; Návod
k použití; Használati útmutató; Návod na použitie;
Navodila za uporabo; Instrukcja użycia; Instrucțiuni
de utilizare; Upute za upotrebu; Uputstvo za
upotrebu; Οδηγίες χρήσης; Инструкции за употреба;
Kullanım talimatları; გამოყენების ინსტრუქცია;
Օգտագործման հրահանգներ; İstifadə qaydaları;
Инструкции по применению; Petunjuk penggunaan;
Arahan penggunaan; 取扱説明書; 사용 지침; 使用說
明; 使用说明书; שומיש תוארוה;שומיש תוארוה;  

12
Contents
EN - ENGLISH.......................................... 13
DE - DEUTSCH ........................................ 22
FR - FRANÇAIS........................................ 33
IT - ITALIANO........................................... 43
ES - ESPAÑOL.......................................... 53
PT - PORTUGUÊS................................... 63
ET - EESTI.................................................. 73
HU - MAGYAR.......................................... 82
PL - POLSKI .............................................. 92
RU - PYCCKИЙ......................................102
JA - 日本語版........................................113
KO - 한국어 ..........................................122
ZHTW - 繁體中文 ..............................131
144.......................................... - AR

13
Intended use
Provox voice prosthesis system is intended for
use of prosthetic voice restoration after total
laryngectomy.
Provox Dilator 17 and Provox Dilator 20
are used for dilating tracheo-esophageal (TE)
punctures that shrink very fast or are too narrow
to insert the selected Provox voice prosthesis.
The dilator may also be used to temporarily
block or stent the TE puncture.
For Home Care Use the dilator is intended for
single patient re-use, and may only be used
as part of Provox NID system. It shall only
be used by patients with sufcient manual
dexterity, acceptable vision and satisfactory
cognitive ability.
For Professional Use the dilator may be re-used
by a clinician in clinic and shall be re-sterilized
between patients.
Contraindications
• The device is not intended to be used by
patients that have not received adequate
training by their clinician.
• The device is not intended to be used for
puncture dilation at the time of surgical
creation of the puncture.
• Do not use the device in case of a small
tracheostoma where the dilator could
obstruct breathing.
Device description
Provox Dilator 17 and Provox Dilator 20 are
tapered curved silicone rods used for dilating
(increase the diameter of) TE punctures. Provox
ENGLISH

14
Dilator 17 shall be used with Provox voice
prostheses with an outer diameter of 17 Fr and
Provox Dilator 20 with outer diameter 20 Fr.
The dilator shall only be used and be prescribed
for patient use, by clinicians trained in the care
and rehabilitation of laryngectomized patients.
Provox Dilator Figure 1
1.1: Medallion
1.2: Safety strap
1.3: Device handle
1.4: Notch
1.5: Retention collar
1.6: Tip
The size is marked on the medallion.
Dimensions:
Provox Dilator 17: The diameter is 11.5 Fr at
the tip and increases to 19 Fr.
Provox Dilator 20: The diameter is 13 Fr at the
tip and increases to 22 Fr.
Length between tip and notch: 60 mm/2.5
inches; length between retention collar and
notch: 20 mm
Recommended Lubricants
The following water-soluble lubricants are
recommended for use with the dilator:
KY Jelly®
SurgiLube®
Recommended anaesthetizing gel
The following anaesthetizing gel is recommended
for use with the dilator:
Xylocaine®/(Lidocaine) Gel.
CAUTION: Lubricants or anaesthetizing gels
that are not water soluble shall not be used at
any time.

15
WARNINGS
General:
• Do not use the device if it shows any sign of
structural damage. A damaged device may
break and parts of it can enter the airways
and have to be removed immediately.
• Do not use lubricating (anaesthetizing) gel
if the patient has allergies related to these
substances.
• Never remove the medallion from the device.
The medallion is of utmost importance for
the safety. It helps to reduce the risk of the
device accidentally falling into the trachea
(windpipe).
Professional use:
• To avoid cross contamination, use
appropriate hygienic procedures and make
sure that each used device is cleaned,
disinfected, dried and steam sterilized.
• The material in Provox Dilator with-
stands 50 cleaning and steam sterilization
procedures at 137°C/278°F for 3 minutes
or at 134°C/273°F for 18 minutes. Always
ensure mechanical integrity before each
use.
Home care use:
• Never use excessive force to insert or
remove the dilator from the puncture. If you
are unable to insert or remove the dilator
with gentle force, immediately consult your
clinician.
PRECAUTIONS
General:
• It is advisable to lubricate the dilator before the
procedure. Only use water-soluble lubricants
in an appropriate amount. Do not use any kind
of oil or ointment during the procedure. Oil
based lubricants (e.g. Vaseline) will weaken,

16
damage or destroy the device and shall not be
used at any time.
• Make sure that the diameter of the dilator is
adequate for the puncture. Over-dilatation
may result in leakage around the voice
prosthesis.
• Never use excessive force to insert or
remove the dilator from the puncture, this
may cause bleeding or a false route.
• Do not use a contaminated dilator. A
contaminated dilator may cause infection
and inammation.
• Do not pull the safety medallion during
removal. See Operating instruction.
• Do not use the dilator for a too long period
of time as this may damage the esophagus
(food pipe) wall.
Professional use:
• Patients on anticoagulant therapy should
be carefully evaluated for the risk of
hemorrhage prior to dilatation of the TE
puncture.
Home care use:
To reduce the risk of infection:
• Make sure that your hands are thoroughly
clean and dry before using your hands in
the area of your tracheostoma, and before
handling your voice prosthesis and/or
accessories
• Clean and disinfect the device after each use
according to instructions in section Cleaning
and sterilization below.
• If the dilator looks dirty or has air dried in a an
area with a risk of contamination the dilator
should be both cleaned and disinfected
before use. A risk of contamination could
exist if the device has been in contact
with a pet, dropped on the oor or other
gross contamination, or if someone has a
respiratory infection.

17
• During hospitalization it is important to both
clean and disinfect the dilator after use but
also before use since there 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.
Adverse events
Consult your clinician if you:
• bleed from the puncture tract. Bleeding
may be caused by damage of the puncture
tract, damage of the esophageal wall or by
bleeding from esophageal vessels. Minor
bleeding during dilatation is normal. If a
minor bleeding does not stop, you should
consult your clinician.
• accidentally dislodge the dilator. The dilator
may be used for stenting the puncture
during a longer period of time. Accidental
dislodgement during these circumstances
may or may not be followed by shrinkage of
the puncture and subsequent closure.
• experience an allergic reaction against the
lubricating (anaesthetizing) gel. Read the
instructions for use accompanying the used
lubricant.
Instructions for use
Checkout procedures
General:
Always handle the dilator with clean hands or
gloves and avoid touching parts that will enter
the puncture.
Prior to each use check the integrity of the
safety strap by slightly pulling the medallion
with one hand while holding the device handle
with the other hand (Figure 2). Discard the device
if it shows any sign of damage.

18
It is advisable to lubricate the dilator with some
water soluble (anaesthetizing) gel prior to use.
Operating instruction
Home care use:
Make sure that you have a magnifying mirror and
sufcient light to illuminate the tracheostoma.
Avoid swallowing once the voice prosthesis
is removed and the puncture is open since this
may lead to aspiration of saliva and/ or coughing.
Keeping your mouth open can help you avoid
swallowing for short periods.
Do not clean, remove, or otherwise manipulate
Provox NID voice prosthesis (or use Provox
Dilator) immediately after a meal since the
stimulation of the puncture tract immediately
after eating may lead to gagging and/or vomiting.
Make sure that you have completely understood
and fully practiced all procedures under the
supervision of your clinician before you perform
any procedure on your own.
Rinse the dilator in drinking water before use
(Figure 3).
Lubricate the part of the dilator that will enter
the puncture using a thin layer of water soluble
(anaesthetizing) gel (Figure 4) if required.
Remove Provox NID voice prosthesis from
the TE puncture before inserting the dilator.
Make sure the puncture tract is empty and/
or open.
Probe the puncture with the tapered tip of
the dilator with the curve of the dilator directed
downwards, and slowly and gently insert the
device until you reach the stop in front of the
handle (Figures 5-7).
Keep the dilator in this position for the
desired amount of time. The time needed to
sufciently dilate the puncture tract to facilitate

19
voice prosthesis insertion varies from person
to person.
You shall carefully tape the safety medallion
to the skin while you wait (Figure 8).
Once the dilator has been in the puncture tract
for the desired amount of time, gently remove
the dilator by pulling the handle (Figure 9).
Do not pull the safety medallion.
Insert Provox NID voice prosthesis using
the standard procedure.
Problem solving:
There might be several possible causes to why
you are unable to insert the dilator, such as wrong
angle/direction when inserting, shrinkage of
puncture or deformation of the puncture tract.
If this should occur never use force to insert
the dilator, you must consult your clinician
immediately.
If you have inserted the dilator too far into the
puncture tract, you might have used the product
in the wrong way or might have an enlarged
puncture tract. If this occurs gently try to retrieve
the device by pulling the medallion. You should
never use force. If you cannot retrieve the device,
consult your clinician immediately.
Professional use:
Remove the voice prosthesis from the TE
puncture.
Probe the puncture with the tapered tip of the
dilator of adequate diameter, with its curvature
directed downwards. Gently insert the device
until the stop of the handle.
Keep the dilator in this position for the desired
amount of time. The waiting time needed for
dilation can vary. Tape the medallion to the skin
during the waiting time.

20
Cleaning and sterilization
Home care use:
Clean and disinfect the dilator after each use.
To clean the dilator mix 2 drops of dish soap
in 250 ml (8,5  oz) warm, 50°-100°C/122°-
212°F, drinking water. Place the dilator in the
mixture (Figure 10).
Gently rub the dilator for 15 seconds to
remove mucus and debris (Figure 11).
Rinse it in drinking water (Figure 12).
Disinfect the dilator by soaking it in hydrogen
peroxide 3% for 60 minutes or ethanol 70%
for 10 minutes or isopropyl alcohol 70% for 10
minutes (Figure 13).
After cleaning and disinfecting the device,
place the dilator on clean gauze and leave it to
air dry (Figure 14). When the dilator is dry,
store it at room temperature in a clean closed
container. Make sure that the stored device is
protected from both heat and direct sunlight.
Caution: Do not clean or disinfect by any other
method as this might cause product damage
and injury.
Professional use:
Cleaning, disinfection and sterilization are
described in “Instructions for cleaning and
sterilization”. If this information is missing,
please contact your supplier or visit our website
on www.atosmedical.com.
The material in Provox Dilator withstands
50 cleaning and steam sterilization procedures
at 137°C/278°F for 3 minutes or at 134°C/273°F
for 18 minutes. Always ensure mechanical
integrity before each use.