Atos Tracoe Twist Plus Istruzioni per l'uso

Tipo
Istruzioni per l'uso
TRACOE® twist plus Tracheostomy Tubes
TRACOE® twist plus Tracheostomiekanülen
REF 311, REF 312, REF 313,
REF 314, REF 316, REF 888-316
TRACOE medical GmbH
Reichelsheimer Straße 1 / 3, 55268 Nieder-Olm / Germany
Tel.: +49 6136 9169-0, Fax: +49 6136 9169-200
[email protected], www.tracoe.com
EN Instructions for Use
DE Gebrauchsanweisung
FR Instructions d’utilisation
IT Istruzioni d’uso
ES Instrucciones de uso
PT Instruções de uso
DA Brugsanvisning
FI Käyttöohje
NO Bruksanvisning
HU Használati utasítás
SV Bruksanvisning
NL Gebruiksaanwijzing
HR Upute za uporabu
SL Navodila za uporabo
CS Návod k použití
RO Instrucţiuni
TR Kullanma talimatı
RU инструкция по применению
PL Instrukcja używania
EL
KO
ZH
AR
TRACOE medical GmbH
Reichelsheimer Straße 1 / 3, 55268 Nieder-Olm / Germany
Tel.: +49 6136 9169-0, Fax: +49 6136 9169-200
[email protected], www.tracoe.com
2022-08
801511
4.0
M
C
6
2a
7b
7a
2b
6
7
2
3
1
4
5
REF
311
REF
312
REF
313
REF
314
REF
316
REF
888-
316
1––––
–1–––
––1––
–––1–
––––1
–––––1
–1–1–1
212121
111111
–1–1–1
––––11
111111
D
10
6
9
11
12
9a
MF 1
DE / Achtung. Gebrauchsanweisung beachten · EN /
Warning. Please read Instructions for Use · FR / Attention.
Respecter le mode d’emploi · IT / Attenzione. Consultare
le istruzioni per l'uso · ES / Atención. Siga las instrucciones de uso ·
PT / Atenção. Ter atenção às instruções de utilização · DA / Vigtigt:
Følg brugsanvisningen · FI / Huomio. Noudata käyttöohjetta ·
NO / OBS. Følg bruksanvisningen · HU / Figyelem. Olvassa el a
használati útmutatót · SV / OBS! Se bruksanvisningen · NL / Let op.
Rekening houden met de gebruiksaanwijzing · HR / Upozorenje.
Pridržavajte se uputa za uporabu · SL / Pozor. Upoštevajte navodila
za uporabo · CS / Pozor. Respektujte návod k použití · RO / Atenţie.
Respectaţi instrucţiunile de utilizare · TR / Dikkat. Kullanma talimatına
dikkat ediniz · RU /    
 · PL / Ostrzeżenie. Zajrzyj do instrukcji używania ·
EL /  · KO / 주의. 사용
명서를 준수하십시오 · ZH / 注意。注意使用说明书
·  / AR ·  / HE
DE / Medizinprodukt · EN / Medical Device ·
FR / Dispositif médical · IT / Dispositivo medico ·
ES / Dispositivo médico · PT / Dispositivo médico · DA / Medicinsk
udstyr · FI / Lääkinnällinen laite · NO / Medisinsk enhet · HU / Orvosi
eszköz · SV / Medicinteknisk produkt · NL / Medisch hulpmiddel ·
HR / Medicinski proizvod · SL / Medicinski pripomoček ·
CS / Zdravotnický prostředek · RO / Dispozitiv medical · TR / Tıbbi
cihaz · RU /  · PL / Wyrób medyczny ·
EL /  · KO / 의료 기기 · ZH / 医疗器械
/AR ·  / HE
EN / Federal (USA) law restricts this device to the sale
by or on the order of a physician · ES / Siguiendo las
leyes federales estadounidenses, la venta de este dispositivo está
sometida a prescripción medica ·
DE / Artikelnummer · EN / Item number · FR / Référence ·
IT / Codice prodotto · ES / Número de artículo ·
PT / Número do artigo · DA / Artikelnummer ·
FI / Tuotenumero · NO / Artikkelnummer · HU / Cikkszám ·
SV / Katalognummer · NL / Artikelnummer · HR / Broj artikla ·
SL / Številka artikla · CS / Číslo výrobku · RO / Numărul de articol ·
TR / Ürün numarası · RU /   · PL / Numer
katalogowy · EL /  · KO / 품목 번호 · ZH / 产品编号
· / AR ·  / HE
23
DE / Chargencode · EN / Batch code · FR / Code de lot ·
IT / Numero di lotto · ES / Código de lote · PT / Código
do lote · DA / Batchkode · FI / Eräkoodi · NO /
Chargekode · HU / Tételkód · SV / Satsnummer · NL / Lotcode ·
HR / Oznaka serije · SL / Koda šarže · CS / Kód šarže · RO / Cod
serie de producţie · TR / Parti kodu · RU /  · PL / Kod
partii · EL /  · KO / 생산 단위 · ZH / 批次编码
· / AR ·  / HE
DE / Hersteller · EN / Manufacturer · FR / Fabricant ·
IT / Produttore · ES / Fabricante · PT / Fabricante ·
DA / Producent · FI / Valmistaja · NO / Produsent ·
HU / Gyártó · SV / Tillverkare · NL / Fabrikant · HR / Proizvođač ·
SL / Proizvajalec · CS / Výrobce · RO / Producător · TR / Üretici ·
RU /  · PL / Wytwórca· EL /  ·
KO / 제조사 · ZH / 生产商 · / AR · / HE
DE / Herstellungsdatum · EN / Date of manufacture ·
FR / Date de fabrication · IT / Data di produzione ·
ES / Fecha de fabricación · PT / Data de fabricação ·
DA / Produktionsdato · FI / Valmistuspäivä · NO / Produksjonsdato ·
HU / Gyártási dátum · SV / Tillverkningsdatum · NL / Fabricagedatum ·
HR / Datum proizvodnje · SL / Datum proizvodnje · CS / Datum
výroby · RO / Data fabricaţiei · TR / Üretim tarihi · RU / 
 · PL / Data produkcji · EL /  ·
KO / 제조일 · ZH / 生产日期 · / HE · / AR
DE / Verwendbar bis · EN / Use by date · FR / Utilisable
jusqu’au · IT / Utilizzare entro il · ES / Fecha de cadu-cidad ·
PT / Utilizável até · DA / Anvendes inden ·
FI / Käytettävä ennen · NO / Kan brukes til ·
HU / Felhasználhatóság dátuma · SV / Används före – utgångsdatum ·
NL / Bruikbaar tot · HR / Upotrebljivo do · SL / Uporabno do ·
CS / Použitelné do · RO / Data expirării · TR / Son kullanma tarihi ·
RU /  · PL / Użyć do daty · EL /  · KO /
통기한 · ZH / 保质期至 · / AR · / HE
23
DE / Sterilisiert mit Ethylenoxid · EN / Sterilized with
Ethylene oxide · FR / Stérilisé à l‘oxyde d‘éthylène ·
IT / Sterilizzato con ossido di etilene · ES / Esterilización con óxido
de etileno · PT / Esterilização com óxido de etileno ·
DA / Sterilisation med ethylenoxid · FI / Steriloitu etyleenioksidilla ·
NO / Sterilisering med etylenoksid · HU / Sterilizáció etilénoxiddal ·
SV / Sterilisering med etylenoksid · NL / Sterilisatie met
ethyleenoxide · HR / Sterilizirano etilen oksidom · SL / Sterilizirano z
etilenoksidom · CS / Sterilizováno ethylenoxidem · RO / Sterilizat cu
oxid etilenic · TR / Etilenoksit ile sterilize edilmiştir ·
RU /  · PL / Sterylizowany
tlenkiem etylenu · EL /  · KO / 에틸
렌으로소독살균되었습니다 · ZH / 乙撑氧 (Ethylene oxide) 灭菌
· / AR ·  / HE
DE / Nicht erneut sterilisieren · EN / Do not resterilize ·
FR / Ne pas restériliser · IT / Non risterilizzare · ES / No
esterilizar de nuevo · PT / Não esterilizar de novo ·
DA / Må ikke resteriliseres · FI / Ei saa steriloida uudelleen ·
NO / Ikke sterilisert på nytt · HU / Tilos újrasterilizálni · SV / Får ej
återsteriliseras · NL / Niet opnieuw steriliseren · HR / Nemojte
ponovno sterilizirati · SL / Ne sterilizirajte znova · CS / Znovu
nesterilizujte · RO / Nu se sterilizează din nou · TR / Tekrar sterilize
etmeyiniz · RU /    · PL / Nie
resterylizować · EL /  · KO / 방사선
으로 멸균처리됨 · ZH / 经辐射消毒 · / AR · 
/ HE
DE / Nicht wiederverwenden · EN / Do not reuse ·
FR / Ne pas réutiliser · IT / Non riutilizzare · ES / No
reutilizar · PT / Não reutilizar · DA / Må ikke genanvendes ·
FI / Ei saa käyttää uudelleen · NO / Må ikke benyttes igjen ·
HU / Tilos újra felhasználni · SV / Endast för engångsbruk · NL / Niet
opnieuw gebruiken · HR / Ne koristite ponovno. · SL / Ne
uporabljajte znova · CS / Znovu nepoužívejte · RO / Nu se
reutilizează · TR / Tekrar kullanmayınız · RU / 
 · PL / Nie używać powtórnie· EL / 
 · KO / 재사용하지 마십시오. · ZH / 不得回收
利用 · / AR · / HE
45
DE / Einzel-Sterilbarrieresystem mit äußerer Schutz-
verpackung · EN / Single sterile barrier system with
protective packaging outside · FR / Système de barrière
stérile unique avec emballage protecteur extérieur · IT / Sistema di
barriera sterile singola con imballaggio protettivo esterno ·
ES / Sistema de barrera estéril sencillo con embalaje externo
protector · PT / Sistema de barreira estéril simples com embalagem
protetora no exterior · DA / System med enkelt steril barriere og
beskyttende emballage udvendigt · FI / Yksi steriili estojärjestelmä ja
suojapakkaus ulkopuolella · NO / Enkelt sterilt barrieresystem med
beskyttende utvendig emballasje · HU / Szimpla steril zárórendszer
külső védőcsomagolással · SV / Enskilt sterilbarriärsystem med
skyddsförpackning utanför · NL / Enkelvoudig steriel barrièresysteem
met beschermende verpakking aan de buitenkant · HR / Sustav jedne
sterilne obloge sa zaštitnom vanjskom ambalažom · SL / Enojni sterilni
pregradni sistem z zunanjo zaščitno embalažo · CS / Systém sterilní
bariéry s vnějším ochranným obalem · RO / Sistem cu o singură
barieră sterilă, cu ambalaj de protecie la exterior · TR / Dıştan
koruyucu ambalajlı tek steril bariyer sistemi · RU / 
      ·
PL / System pojedynczej bariery sterylnej z zewnętrznym
opakowaniem ochronnym · EL / 
 · KO / 외부 보호 포장이 있는
단일 멸균 장벽 시스템 · ZH / 带外层保护包装的单套无菌屏障系统
/ HE · 
/ AR
DE / Einzel-Sterilbarrieresystem · EN / Single sterile
barrier system · FR / Système de barrière stérile unique ·
IT / Sistema di barriera sterile singola · ES / Sistema de
barrera estéril sencillo · PT / Sistema de barreira estéril simples ·
DA / System med enkelt steril barriere · FI / Yksi steriili
estojärjestelmä · NO / Enkelt sterilt barrieresystem · HU / Szimpla
steril zárórendszer · SV / Enskilt sterilbarriärsystem · NL / Enkel-
voudig steriel barrièresysteem · HR / Sustav jedne sterilne obloge ·
SL / Enojni sterilni pregradni sistem · CS / Systém sterilní bariéry ·
RO / Sistem cu o singură barieră sterilă · TR / Tek steril bariyer
sistemi · RU /     ·
PL / System pojedynczej bariery sterylnej· EL / 
 · KO / 단일 멸균 장벽 시스템 · ZH / 单套无菌屏障
系统 · / AR · / HE
45
DE / Trocken aufbewahren · EN / Store in a dry place · FR /
Conserver au sec · IT / Conservare in luogo asciutto ·
ES / Conservar en un lugar seco · PT / Guardar em local
seco · DA / Opbevares tørt · FI / Säilytettävä kuivassa ·
NO / Oppbevares på et tørt sted · HU / Száraz helyen tárolandó ·
SV / Förvaras torrt · NL / Droog bewaren · HR / Čuvajte na suhom
mjestu · SL / Hranite na suhem · CS / Uchovávejte v suchu · RO / A se
păstra la loc uscat · TR / Kuru şekilde saklayınız · RU / 
 · PL / Chronić przed wilgocią· EL / 
 · KO / 건조한 곳에 보관하십시오. · ZH / 需保存于干燥处 ·
/ AR · / HE
DE / Temperaturbegrenzung · EN / Temperature limits · FR /
Limitation de température · IT / Limite di temperatura ·
ES / Límite de temperatura · PT / Limitação da temperatura ·
DA / Temperaturbegrænsning · FI / Lämpötilarajat ·
NO / Temperaturbegrensing · HU / Hőmérsékleti tartomány ·
SV / Tillåtet temperaturområde · NL / Temperatuurbegrenzing ·
HR / Ograničenje temperature · SL / Omejitev temperature ·
CS / Omezení teploty · RO / Limitare a temperaturii · TR / Sıcaklık
sınırlaması · RU /  · PL / Dopuszczalna
temperatura· EL /  · KO / 온도 제한 · ZH / 温度
限值范围 · / AR · / HE
DE / Von Sonnenlicht fernhalten · EN / Protect from
sunlight · FR / Protéger de l’ensoleillement · IT / Non
esporre alla luce del sole · ES / Mantener alejado de la luz
solar · PT / Manter afastado da luz solar · DA / Beskyttes mod sollys ·
FI / Säilytettävä auringonvalolta suojattuna · NO / Må holdes unna
sollys · HU / Napfénytől távol tartandó · SV / Skyddas från solljus ·
NL / Beschermen tegen zonlicht · HR / Držite podalje od sunčeve
svjetlosti · SL / Varujte pred sončno svetlobo · CS / Chraňte před
slunečním světlem · RO / A se feri de razele solare · TR / Güneş
ışığından uzak tutunuz · RU /  ·
PL / Trzymać z dala od światła słonecznego· EL / 
 · KO / 직사광선에 노출되지 않도록
십시오 · ZH / 避免阳光直射 ·       / AR
· / HE
67
DE / Phthalat-frei (z. B. DEHP) · EN / Not made with
phthalates (e.g. DEHP) · FR / Sans phtalates (par ex.
DEHP) · IT / Senza ftalati (per es. DEHP) · ES / Sin
ftalatos (p. ej. DEHP) · PT / Sem ftalatos (por ex. DEHP) ·
DA / Phthalat-fri (f.eks. DEHP) · FI / Ftalaatition (esim. DEHP) ·
NO / Ftalatfritt (f.eks. DEHP) · HU / Ftalátmentes (pl. DEHP) ·
SV / Ftalatfri (t. ex. DEHP) · NL / Niet gefabriceerd met ftalaten (bijv.
DEHP) · HR / Ne sadrži ftalate (npr. DEHP) · SL / Brez ftalatov (npr.
DEHP) · CS / Bez obsahu ftalátů (např. DEHP) · RO / Nu conţine
ftalaţi (de ex. DEHP) · TR / Ftalat içermez (örn. DEHP) · RU / 
    · PL / Nie zawiera
ftalanów (np. DEHP)· EL / 
 · KO / (디에탈헥실프탈레이트) 포함 · ZH / 不含邻苯二甲酸盐
 / AR · / HE
DE / Nicht mit natürlichem Latex hergestellt · EN / Not
made with Natural Rubber latex · FR / Non fabriqué avec
du latex naturel · IT / Non realizzato con lattice naturale ·
ES / No elaborado con látex natural · PT / Não fabricado com látex
natural · DA / Ikke fremstillet med naturligt latex · FI / Ei valmistettu
luonnonlateksista · NO / Ikke produsert med naturlig latex ·
HU / Nem természetes latexből készült · SV / Tillverkad utan
användning av naturlig latex · NL / Niet gefabriceerd met natuurlijk
latex · HR / Nije proizvedeno s prirodnim lateksom · SL / Ni izdelano
z naravnim lateksom · CS / Není vyrobeno z přírodního latexu ·
RO / Nu este produs cu latex natural · TR / Doğal lateksle
üretilmemiştir · RU /     ·
PL / Nie zawiera lateksu kauczuku naturalnego · EL / 
 · KO / 천연 라텍스로 만들지 않음 ·
ZH / 制作过程未添加天然乳胶 · / AR
· / HE
LATEX
67
DE / Bei beschädigter Verpackung nicht verwenden · EN /
Do not use if package is damaged · FR / Ne pas utiliser en
cas d’emballage endommagé · IT / Non utilizzare se la
confezione è danneggiata · ES / No utilizar si el envase está dañado ·
PT / Não utilizar em caso de embalagem danificada · DA / Må ikke
anvendes, hvis emballagen er beskadiget · FI / Älä käytä, jos
pakkaus on vahingoittunut · NO / Må ikke benyttes hvis emballasjen
er skadet · HU / Tilos felhasználni, ha a csomagolás sérült ·
SV / Används inte om förpackningen är skadad · NL / Niet
gebruiken bij beschadigde verpakking · HR / Proizvod ne koristite
ako je pakiranje oštećeno · SL / Ne uporabljajte, če je embalaža
poškodovana · CS / Nepoužívat při zjištění poškození obalu ·
RO / Nepoužívat při zjištění poškození obalu · TR / Ambalajı
hasarlıysa kullanmayınız · RU / 
 · PL / Nie używać, jeżeli opakowanie jest
uszkodzone· EL / 
 · KO / 포장이 손상된 경우 사용하지
마십시오. · ZH / 如包装破损,不得使用 · /
AR · / HE
DE / Ausklappbare Bildseiten · EN / Pull-out image
pages · FR / Pages d’illustration dépliables · IT / Pagine
grafiche ripiegabili · ES / Páginas del anverso desplegables ·
PT / Páginas ilustrativas desdobráveis · DA / Billedsider, der kan
foldes ud · FI / Avattavat kuvasivu · NO / Utbrettbare sider med
illustrasjoner · HU / Kihajtható lapok · SV / Utvikbara bildsidor ·
NL / Uitklapbare fotopagina‘s · HR / Otklopive stranice sa slikama ·
SL / Zložljive strani s slikami · CS / Výklopné stránky s obrázky ·
RO / Pagini pliante cu ilustraţii · TR / Açılabilen resimli sayfalar ·
RU /  · PL / Rozkładane strony z
ilustracjami · EL /  · KO / 접이식
그림 페이지 · ZH / 可折叠图片页 · 
/ AR · 
/ HE
DE / Packungsinhalt · EN / Packaging Content ·
FR / Contenu de l’emballage · IT / Contenuto della
confezione · ES / Contenido del envase ·
PT / Conteúdo da embalagem · DA / Pakningsindhold ·
FI / Pakkauksen sisältö · NO / Pakningsinnhold · HU / A csomag
tartalma · SV / Förpackningens innehåll · NL / Inhoud verpakking ·
HR / Sadržaj pakiranja · SL / Vsebina embalaže · CS / Obsah balení ·
RO / Conţinutul ambalajului · TR / Paket içeriği · RU / 
 · PL / Zawartość opakowania· EL / 
 · KO / 포장 내용물 · ZH / 包装内容 / AR
· / HE
1
89
EN / Fenestrated Tube (REF 312, REF 888-316) · DE /
Kanüle mit Fensterung (REF 312, REF 888-316) ·
FR / Canule fenêtrée (REF 312, REF 888-316) · IT /
Cannula fenestrata (REF 312, REF 888-316) · ES / Cánula fenes-
trada (REF 312, REF 888-316) · PT / Cânula fenestrada (REF 312,
REF 888-316) · DA / Fenestreret kanyle (REF 312, REF 888-316)
· FI / Aukollinen kanyyli (REF 312, REF 888-316) · NO / Fenes-
trert kanyle (REF 312, REF 888-316) · HU / Fenesztrált kanül
(REF 312, REF 888-316) · SV / Fenestrerad kanyl (REF 312, REF
888-316) · NL / Gevensterde canule (REF 312, REF 888-316) ·
HR / Fenestrirana kanila (REF 312, REF 888-316) · SL / Kanila
z oknom (REF 312, REF 888-316) · CS / Fenestrovaná ka-
nyla (REF 312, REF 888-316) · RO / Canulă cu fereastră
(REF 312, REF 888-316) · TR / Fenestrasyonlu kanül
(REF 312, REF 888-316) · RU / Канюля с фонационным
окном (REF 312, REF 888-316) · PL / Rurka z fenestracją
(REF 312, REF 888-316) · EL / (REF 312, REF 888-316) ·
KO / (REF 312, REF 888-316) ·
ZH / (REF 312, REF 888-316) · (REF 312, REF
888-316) · / AR
DE / Lieferumfang · EN / Scope of supply · FR / Contenu de
l’emballage · IT / Ambito di fornitura · ES / Volumen de
suministro · PT / Volume de fornecimento · DA / Levering ·
FI / Toimituksen sisältö · NO / Leveringens innhold · HU / Szállítási
terjedelem · SV / Detta ingår i leveransen · NL / Leveringsomvang ·
HR / Opseg isporuke · SL / Obseg dobave · CS / Obsah balení ·
RO / Descrierea echipamentelor furnizate · TR / Teslimat kapsamı ·
RU /   · PL / Zakres dostawy ·
EL /  · KO / 공급 범위 · ZH / 供货范围
· / AR · / HE
DE / Hier öffnen · EN / Peel here · FR / Ouvrir ici
· IT / Strappare qui · ES / Abra aquí · PT / Descolar
aqui · DA / Åbn her · FI / Repäise tästä · NO / Åpne
her · HU / Itt nyílik · SV / Öppnas här · NL / Hier openen ·
HR / Otvoriti ovdje · SL / Odprite tukaj · CS / Zde otevřít ·
RO / Deschidei aici · TR / Buradan açın · RU /  ·
PL / Tu otwierać · EL /   · KO / 여기를 벗기시오 ·
ZH / 从此处撕开 · / AR · / HE
Peel here.
Hier öf
fnen.
89
10 11
Instructions for Use for TRACOE® twist plus
Tracheostomy Tubes
NOTE:
Please read the instructions for use carefully. They are part of
the described product and must be available at all times. For your
own and your patients’ safety, please observe the following safety
information.
The illustrations to which the text refers can be
found on the (foldout) illustrated pages at the beginning of these
instructions. The numbers and letters in brackets refer to the
respective illustrations and product components of the tracheos-
tomy tube. The symbols and icons used are explained on pages 1
to 5.
1. General Information
CAUTION: The product may only be used by physicians and other
trained staff responsible for the patient’s care! The attending doctor
must determine the correct size and type.
Intended Purpose: This medical device is a tracheostomy tube.
Functional Description: The tracheostomy tube ensures that
respired air passes through the tracheostoma.
The inflated cuff separates the upper from the lower respira-
tory tract, preventing the flow of air from the lungs into the mouth
and vice versa. This ensures that the patient can breathe only
through the tube. The cuff is inflated by filling it with air using the
inflation line. When inflated, the cuff seals the space between the
trachea and the outer cannula wall. This allows efficient ventilation
with ventilation equipment and prevents subglottic secretions from
entering the lower respiratory tract.
Fenestrated cannulas allow some of the air needed for
speaking to reach the upper respiratory tract through the fenestra-
tion. Airway resistance in the upper respiratory tract is also reduced.
See below for a more detailed functional description.
EN
10 11
Maximum Useful Life of the Tracheostomy Tube:
with cuff - 29 days,
without cuff - 5 weeks,
from first use (see Chapter 5 “General Precautions”). This maximum
period of use also includes any periods when the tracheostomy
tubes or inner cannulas are not in use.
Product for Single-Patient Use: Multiple use by one and the same
patient during the period of use is permitted.
Product Info Card: This product is supplied with a product info card
with two detachable labels. The labels show product details. Keep
the info card separately to facilitate reordering. The detachable label
can be affixed to the patient’s medical records, for example.
2. General Description
The product consists of an outer cannula (1) with a cuff (2) or without
a cuff and an inner cannula with a 15 mm connector (3), which is
already inserted in the outer cannula and is locked with a locking
ring (4). Two replacement inner cannulas (9/9a), each with a 15 mm
connector, are also supplied.
The cuff is inflated or deflated using the filling valve with pilot balloon
(2a), which can be found on the inflation line (2b).
The outer cannula is made of a radiopaque polyurethane and is
attached to a neck flange (5) that can swivel on 2 axes (cardanic
suspension).
The perforated obturator (6) is already inserted in the inner cannula
and makes it easier to insert the tube. The perforation also allows
the use of a Seldinger wire (Ø 1.27 ± 0.04 mm, e.g. REF 518) for
cannulation/recannulation.
3. Indications
The products are suitable for patients where access to the respira-
tory tract is required via a tracheostoma.
Tubes without a cuff are particularly suited for patients who
breathe spontaneously but need to use a tube.
Tubes with a cuff are suitable for patients where access to
the respiratory tract is required via a tracheostoma with the trachea
sealed.
Fenestrated tubes facilitate speech in patients with an intact
larynx.
Tubes with a suction line (7) are for use in patients where
suction of subglottic secretion is indicated.
EN
12 13
4. Contraindications
4.1 Absolute contraindications
Do not use the occlusion cap (10)/ speaking valve in laryn-
gectomised patients (patients without a larynx) - risk of suffocation!
4.2 Relative contraindications
Relative contraindications are cases where the risks and benefits of
the procedure must be carefully evaluated:
Paediatric use
Unusually deep-lying trachea (e.g. in obese patients) or diffi-
cult anatomical conditions
5. General Precautions
You are strongly advised to keep a ready-to-use spare tube
and several spare inner cannulas at the patient’s bedside. Store in a
clean and dry state.
Check the tube for integrity and correct function prior to use/
insertion. Check, for example, for the absence of obstruction, cuff
seal, correct and stable fit of the inner cannula inside the outer can-
nula, absence of kinks, stable connection between the tube and
neck flange, etc. The cuff material must not be brittle. If the product
is damaged, replace with a new product.
Do not use force on the tracheostomy tube, as this may
damage or break it. If the connections at the 15 mm connector are
tightly fixed, always use a disconnect wedge approved for tracheos-
tomy tubes.
Keep the 15 mm connector (3) clean and dry.
When changing the inner cannula, always ensure that the
inflation line (2b) of the cuff is not positioned between the inner and
outer cannulas as it may get trapped and damaged.
When repositioning the patient in bed, ensure that the patient
does not lie on the pilot balloon (2a), as this would increase the cuff
pressure and may damage the trachea.
During mechanical ventilation and frequent changes of the
patient’s position or manipulation of the tube, the inner cannula may
become separated from the outer cannula.
The use of tracheostomy tubes can lead to pressure points
and skin irritation. To avoid this, we recommend placing a pad
underneath the neck flange (e.g. TRACOE purofoam REF 958 or
REF 959 or TRACOE softpad REF 969).
To avoid damage to the material, the cuff should not be in
contact with lidocaine-containing aerosols or any ointments.
All components of the cuff inflation system must lie freely and
without kinks during the cuff pressure check. Otherwise it is possible
EN
12 13
that the pressure will be displayed incorrectly.
Thin cuffs are to some extent permeable to water vapour.
Therefore, condensate may accumulate in the cuff. Where quantities
are small, this is of no significance. However, if larger quantities of
condensate are inadvertently aspirated into the inflation line, it is no
longer possible to measure and adjust the cuff pressure correctly
and the tube must be replaced. Before removing the tube, remove
as much air or water from the cuff as possible using a syringe.
When using together with other medical devices, the respec-
tive instructions for use must be observed. If in doubt, contact the
manufacturer.
The use of cuffed tubes on aircraft is not advisable without
permanent cuff pressure regulation, as fluctuations in the cuff pres-
sure may occur during the flight.
6. Warnings
Do not use if the sterile packaging is not intact.
Use the locking ring (4) to loosen the inner cannula (C). Do
not turn the 15 mm connector (3), as this may cause the inner can-
nula inside the outer cannula to rotate and the air supply to be inter-
rupted.
Never use fenestrated inner cannulas for ventilation.
Use the occlusion cap (10) only with fenestrated tubes (outer +
inner cannula) and an uninflated cuff.
Do not use a speaking valve when the patient is asleep.
When using laser or electrosurgical treatment equipment,
ensure that the tracheostomy tube is at a safe distance. There is a
risk of fire and toxic gases and the tube may get damaged.
Select the correct tube to ensure that the fenestration (if
applicable) is positioned in the tracheal lumen at a sufficient distance
from the stoma canal. Poor positioning exposes ventilated patients
to the risk of emphysema. Granulation tissue may also form or air-
way resistance may increase if speaking valves or occlusion caps
are used.
If a fenestrated tube is used, there is a risk of increased for-
mation of granulation tissue.
The cuff pressure can change, for example due to altitude
changes (e.g. in an aircraft), or if laughing gas is used as an anaes-
thetic or during the connection of a handheld manometer.
Excessive cuff pressure poses a risk of permanent damage
to the trachea.
Excessive cuff pressure may cause cuff herniation.
Insufficient cuff pressure may result in inadequate ventilation
and poses a risk of aspiration.
EN
14 15
Ensure that the correct Luer connectors are used (e.g. 2a +
7a).
During insertion and removal of the tube, irritation, the need
to cough or bleeding may occur.
7. Adverse Reactions
Pressure points, skin irritation, granulation tissue, the need to cough,
difficulty swallowing and bleeding.
8. Inserting the Tube
8.1 Preparing the Tube
1. Check the pack content for completeness (D).
2. For tubes with a cuff, check the cuff (2) for leakage by inflat-
ing it. For this purpose, inflate the cuff with a handheld manometer,
for example the TRACOE cuff pressure monitor REF 720, to a pres-
sure of 50 cm H22O (≈ 36.78 mm Hg) and wait for 1 minute to see
whether the cuff becomes deflated. If the cuff is leak-tight, remove
all air from the cuff with a syringe. Push the cuff upwards in the
direction of the neck flange (5) to facilitate insertion. If there is any
leakage, use a replacement tube and return the defective product as
instructed in Chapter 13.
8.2 Preparing the Patient
Ensure that the patient is well pre-oxygenated before cannu-
lation or recannulation.
Slightly overextend the patient’s neck, if possible, to facilitate
insertion.
In case complications arise during cannulation or recannula-
tion, a tube with a smaller diameter should be at hand for emer-
gency use. In addition, take appropriate safety measures that allow
the doctor to carry out short-term ventilation using translaryngeal
intubation or a laryngeal mask.
8.3 Inserting the Tube
Carry out the following steps:
1. When inserting the tube (1), take care that the obturator (6) is
not inadvertently pushed back into the tube. This can easily be pre-
vented by holding both the tube and obturator firmly with one hand.
To aid insertion, apply a thin layer of water-soluble lubricant to the
protruding part of the obturator at the patient end and to the adja-
cent section of the tracheostomy tube, including the cuff.
2. Once the tube has been inserted into the patient’s trachea,
remove the obturator immediately.
3. For ventilation, securely connect the inner cannula with the
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14 15
standardised 15 mm connector (3) to a ventilation machine.
For Cuffed Tubes:
4. Inflate the cuff via the filling valve (2a). Adjust the cuff pres-
sure to the individual ventilation therapy and check at regular inter-
vals. Typically, the pressure should be between 20 cm H22O (≈
15 mm Hg) and 30 cm H22O (≈ 22 mm Hg).
A fall in cuff pressure occurs when a handheld manometer is
attached. This effect is more pronounced with smaller tubes.
5. Attach the neck strap (12) to the neck flange (5) to fix the
tube in place on the patient’s neck.
6. Check the position of the tube as well as its correct function
(see Chapter 6 “Warnings”). If required, carefully suction the trachea
and tube to ensure that the airways are unobstructed.
7. Now check the cuff pressure to ensure that the cuff has not
been damaged during insertion.
8.4 Removing the Tube
Prepare to remove the tube as follows:
Bend the patient’s head slightly backwards and
Completely deflate the cuff of cuffed tubes (see Chapter 8.5).
8.5 Deflating the Cuff
Before deflating the cuff, ensure that as little secretion as possible
can enter the bronchia.
While the cuff is being deflated, secretions should be removed using
a suction catheter inserted through the tube. If a tube with subglottic
suction has been used, the subglottic space should also be suc-
tioned before deflating the cuff, see Chapter 9.5.
To deflate the cuff, connect a syringe with a standard male Luer
connecter to the filling valve (2a). Completely remove all air/any pos-
sible condensate
If the cuff cannot be deflated, the following measures should be
taken:
Remove the inner cannula. Ensure that the inflation line (2b)
is not kinked and repeat the deflation of the cuff.
If it is still not possible to remove the air/condensate from the
cuff, carefully cut through the inflation line between the 15 mm con-
nector (3) and the neck flange (5).
9. Handling
9.1 Changing the Inner Cannulas
If viscous secretion collects in the inner cannula and cannot be suc-
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16 17
tioned, thus impeding the airflow, replace the inner cannula with a
new or cleaned inner cannula.
Loosen the inner cannula by turning (C) the locking ring (4) and
remove. Once a new inner cannula has been inserted into the outer
cannula, lock in place by turning (C) the locking ring (4) until it clicks
into place.
When inserting the inner cannula, ensure that the inflation line (2b) of
the cuff is not lying between the inner and outer cannulas, otherwise
it may get trapped and damaged.
9.2 Fenestrated Tracheostomy Tubes
Unfenestrated inner cannulas have white locking rings and are
used, for example, during ventilation.
To allow the patient to speak, insert a fenestrated inner cannula
(blue locking ring) in the fenestrated outer cannula. Once the cuff
has been deflated, a speaking valve can be placed on the 15 mm
connector of this inner cannula. The instructions for use of the
respective speaking valve must be observed.
9.3 Occlusion Cap of the Fenestrated Tube for Weaning
The fenestrated inner cannula can be closed by attaching the
enclosed occlusion cap (10) to the 15 mm connector.
CAUTION: When preparing the tube, ensure that the patient’s upper
respiratory tract is unobstructed. The upper respiratory tract can be
cleared by coughing out or suctioning the secretion. The cuff must
be deflated. When closing the tube, the patient’s breathing and vital
signs must be monitored by a nursing professional. If any signs of
breathing difficulties are detected, the occlusion cap must be
removed immediately.
9.4 Keeping the Fenestration Open
If the tube is used over a prolonged period, it must be ensured at
regular intervals that the fenestration is not blocked by secretions,
incrustation or in-growing tissue. If required, replace the tube.
9.5 Application of REF 316, REF 888-316
with Subglottic Suction Line
These tubes are fitted with a soft smooth flat plastic element (7) that
is fixed to the outer curve of the outer cannula and ends with two
openings immediately above the cuff (2). A suction line (7b) is inte-
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16 17
grated into this element. The suction line has a female Luer connec-
tor (7a) at its free end, through which any secretions can be
removed using a syringe. Alternatively, a special suction device with
a vacuum controller connected to the enclosed connectors (11) can
be used. After suctioning, ensure that the Luer connector (7a) is
closed.
CAUTION:
Ensure during suctioning that no excessive vacuum is used
over a prolonged period (maximum of 200 mbar).
To prevent the subglottic area from drying out, we recom-
mend the use of intermittent suction.
The suction line may get blocked due to accumulated secre-
tions or adhesions to the tracheal mucosa. If it is intended to rinse
the subglottic suction line (e.g. with a small amount of air or phys-
iological saline solution), ensure beforehand that the cuff is suffi-
ciently inflated (risk of aspiration).
The subglottic suction line may cause pressure points in the
area of the tracheostoma or may cause the tracheostoma to
become irregular. In such cases, the doctor must decide whether
this type of tube can still be used.
10. Cleaning, Disinfection and Storage
10.1 Cleaning
The tube (outer and inner cannulas) must be cleaned before reuse.
Lukewarm potable water can be used for cleaning. TRACOE medi-
cal recommends the use of the cleaning products offered by
TRACOE for cleaning. Once the tubes have been cleaned, rinse with
potable water and air-dry. When cleaning the outer cannulas, take
care not to damage the cuff.
CAUTION:
Never use aggressive domestic cleaning agents, cleaning
agents for dentures or solvents with a high alcohol content, for
example, as these may have a lasting adverse effect on the function.
Do not heat the tubes to temperatures above 60°C, as the
safety of the products can then no longer be guaranteed.
10.2 Disinfection
Should disinfection appear necessary TRACOE medical can provide
a list of disinfectants on request. The use of unsuitable disinfectants
can result in damage to the product.
Once the tubes have been disinfected, rinse with sterile water, dis-
tilled water or potable water and air-dry.
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Atos Tracoe Twist Plus Istruzioni per l'uso

Tipo
Istruzioni per l'uso