Atos Tracoe Kids Silcosoft Kullanma talimatları

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

2022-10

802020

7.0

M

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

TRACOE® silcosoft® Tracheostomy Tubes for

Neonates / Infants and Children

TRACOE® silcosoft® Tracheostomiekanülen für

Neugeborene / Kleinkinder und Kinder

REF 360, REF 361, REF 362, REF 363,

REF 370, REF 371, REF 372, REF 373

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 użycia

EL

KO

ZH

AR

REF

370

2.5

1a

6

7a 3

2

1b

5b

5a

5

1b

4

2

3

7

7a

6

5c

5b

5a

5

1b

4

2

3

7

7a

6

5c

Image 2: Cuffed Model with proximate

extension and metal obturator

Image 1: Uncuffed model with plastic obturator

Image 3

Image 2: Cuffed Model with proximate

extension and metal obturator

Image 5: Metal obturator

Image 4: Plastic obturator

REF

360

REF

361

REF

362

REF

363

REF

370

REF

371

REF

372

REF

373

1 – – – 1 – – –

– – 1 – – – 1 –

– 1 – – – 1 – –

– – – 1 – – – 1

1 – 1 – 1 – 1 –

– 1 – 1 – 1 – 1

1 1 1 1 1 1 1 1

D

8

9

OP

Size ID

mm

OD

mm

C

mm

TL

mm

OL

mm

OB

mm

BA

2.5 2.5 4.4 26.8 30 55.5 32 120°

3.0 3.0 4.9 28.0 32 57.5 34 120°

3.5 3.5 5.4 29.0 34 59.5 37 120°

4.0 4.0 6.0 29.0 36 61.5 39 120°

REF 360, 362

Size ID

mm

OD

mm

C

mm

TL

mm

OL

mm

OB

mm

BA PL

2.5 2.5 4.4 26.8 30 80 32 120° 15

3.0 3.0 4.9 28.0 32 84 34 120° 17

3.5 3.5 5.4 29.0 34 89 37 120° 20

4.0 4.0 6.0 29.0 36 93 39 120° 22

REF 361, 363

Size ID

mm

OD

mm

C

mm

TL

mm

OL

mm

OB

mm

BA PL

2.5 2.5 4.4 29.0 38 93 40 120° 20

3.0 3.0 4.9 29.0 39 94 41 120° 20

3.5 3.5 5.4 29.0 40 100 43 120° 25

4.0 4.0 6.0 29.0 41 101 44 120° 25

4.5 4.5 6.6 29.0 42 107 45 120° 30

5.0 5.0 7.3 29.0 44 109 48 120° 30

5.5 5.5 8.4 29.0 46 111 50 120° 30

REF 371, 373

Size ID

mm

OD

mm

C

mm

TL

mm

OL

mm

OB

mm

BA

2.5 2.5 4.4 29.0 38 63.5 40 120°

3.0 3.0 4.9 29.0 39 64.5 41 120°

3.5 3.5 5.4 29.0 40 65.5 43 120°

4.0 4.0 6.0 29.0 41 66.5 44 120°

4.5 4.5 6.6 29.0 42 67.5 45 120°

5.0 5.0 7.3 29.0 44 69.5 48 120°

5.5 5.5 8.4 29.0 46 71.5 50 120°

REF 370, 372

REF 360, 362, 370, 372

OD

BA

TL

ID

OB C

OL

REF 361, 363, 371, 373

OD

BA

TL

ID

PL

OB C

OL

ID: inside diameter (clear width) of tube; OD: outside diameter of tube;

C: length of bend; TL: length along centre line from start of neck ﬂange

to bottom of tube; OB: length along outer bend from start of neck ﬂange

to bottom of tube; BA: bending angle; PL: proximal longer; OL: overall

length along center line from bottom of tube to connector end.

DE / Gebrauchsanweisung beachten · EN / Please read Inst-

ructions for Use · FR / Respecter le mode d’emploi

· IT / Consultare le istruzioni per l'uso · ES / Siga las iZstrucci-

ones de uso · PT / Ter atenção às instruções de utilização · DA / Følg

brugsanvisningen · FI / Noudata käyttöohjetta · NO / Følg bruksanvisnin-

gen · HU / Olvassa el a használati útmutatót · SV / Se bruksanvisningen ·

NL / Rekening houden met de gebruiksaanwijzing · HR / Pridržavajte se

uputa za uporabu · SL / Upoštevajte navodila za uporabo · CS / Respek-

tujte návod k použití · RO / Respectaţi instrucţiunile de utilizare ·

TR / Kullanma talimatına dikkat ediniz · RU / Соблюдать инструкцию по

применению · PL / Zajrzyj do instrukcji używania · EL / Ακολουθήστε τις

οδηγίες χρήσης · KO / 사용 설명서를 준수하십시오 · ZH / 注意使用说明

书 يجب مراعاة دليل الاستعمال / AR

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 / 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 / Медицинское изделие · PL / Wyrób medyczny ·

EL / Ιατροτεχνολογικό προϊόν · KO / 의료 기기 · ZH / 医疗器械

جهاز طبي / AR

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 bruksan-

visningen · NL / Let op. Rekening houden met de gebruiksaanwijzing ·

HR / Upozorenje. Pridržavajte se uputa za uporabu · SL / Pozor. Upoš-

tevajte navodila za uporabo · CS / Pozor. Respektujte návod k použití ·

RO / Atenţie. Respectaţi instrucţiunile de utilizare · TR / Dikkat. Kullan-

ma talimatına dikkat ediniz · RU / Внимание! Соблюдать инструкцию

по применению · PL / Ostrzeżenie. Zajrzyj do instrukcji używania ·

EL / Προσοχή. Ακολουθήστε τις οδηγίες χρήσης · KO / 주의. 사용 설

명서를 준수하십시오 · ZH / 注意。注意使用说明书 · تنبيه. يجب مراعاة

دليل الاستعمال / AR

MF 1

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 / Ürünnumarası · RU / Номер артикула · PL / Numer katalogowy ·

EL / Αριθμός είδους · KO / 품목 번호 · ZH / 产品编号 رقم السلعة / AR

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 / Код партии ·

PL / Kod partii · EL / Κωδικός παρτίδας · KO / 생산 단위 · ZH / 批次编码

رمز الشحن / AR

DE / Hersteller · EN / Manufacturer · FR / Fabricant · IT / Produt-

tore · 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 / Производитель · PL / Wytwórca ·

EL / Κατασκευαστής · KO / 제조사 · ZH / 生产商 · الشركة المُصنِّعة / AR

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 / Valmis-

tuspäivä · NO / Produksjonsdato · HU / Gyártási dátum · SV / Tillver-

kningsdatum · NL / Fabricagedatum · HR / Datum proizvodnje ·

SL / Datum proizvodnje · CS / Datum výroby · RO / Data fabricaţiei ·

TR / Üretim tarihi · RU / Дата изготовления · PL / Data produkcji ·

EL / Ημερομηνία κατασκευής · KO / 제조일 · ZH / 生产日期 تاريخ

التصنيع / 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 / Срок годности · PL / Użyć do daty · EL / Χρήση έως · KO / 유통기

한 · ZH / 保质期至 قابل للاستخدام حتى / AR

23

DE / Sterilisiert mit Ethylenoxid · EN / Sterilized with Ethy-

lene oxide · FR / Stérilisé à l‘oxyde d‘éthylène · IT / Steri-

lizzato con ossido di etilene · ES / Esterilización con óxido de etileno ·

PT / Esterilização com óxido de etileno · DA / Sterilisation med ethyleno-

xid · 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 / Стерилизовано оксидом этилена · PL / Sterylizowany tlenkiem

etylenu · EL / Αποστείρωση με αιθυλενοξείδιο · KO / 에틸렌으로소독살균

되었습니다 · ZH / 乙撑氧 (Ethylene oxide) 灭菌 · معقم.ممادة أوكسيد

الأثيلين / AR

DE / Einzel-Sterilbarrieresystem mit äußerer Schutz-

verpackung · EN / Single sterile barrier system with protec-

tive packaging outside · FR / Système de barrière stérile

unique avec emballage protecteur extérieur · IT / Sistema di barrie-

ra sterile singola con imballaggio protettivo esterno · ES / Sistema de

barrera estéril sencillo con embalaje externo protector · PT / Siste-

ma de barreira estéril simples com embalagem protetora no exterior ·

DA / System med enkelt steril barriere og beskyttende emballage ud-

vendigt · FI / Yksi steriili estojärjestelmä ja suojapakkaus ulkopuolella ·

NO / Enkelt sterilt barrieresystem med beskyttende utvendig embal-

lasje · 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 vanjs-

kom 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 protecție la

exterior · TR / Dıştan koruyucu ambalajlı tek steril bariyer sistemi ·

RU / Единая система защиты стерильности с защитной упаковкой

снаружи · PL / System pojedynczej bariery sterylnej z zewnętrznym

opakowaniem ochronnym · EL / Σύστημα μονού στείρου φραγμού με

προστατευτική συσκευασία εξωτερικά · 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 · نظام حاجز

مُعقم أحادي بتغليف واقٍ خارجي / AR

23

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 aurin-

gonvalolta suojattuna · NO / Må holdes unna sollys · HU / Napfénytől tá-

vol tartandó · SV / Skyddas från solljus · NL / Beschermen tegen zonlicht ·

HR / Držite podalje od sunčeve svjetlosti · SL / Varujte pred sončno svet-

lobo · CS / Chraňte před slunečním světlem · RO / A se feri de razele

solare · TR / Güneş ışığından uzak tutunuz · RU / Беречь от солнечных

лучей · PL / Trzymać z dala od światła słonecznego · EL / Να φυλάσσεται

μακριά από το φως του ήλιου · KO / 직사광선에 노출되지 않도록 하십시

오 · ZH / 避免阳光直射 · يجب إبقاؤها بعيدة عن أشعة الشمس / AR

DE / Einzel-Sterilbarrieresystem · EN / Single sterile barrier

system · FR / Système de barrière stérile unique · IT / Sis-

tema 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 ste-

rilbarriärsystem · 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 / Единая система защиты стерильности ·

PL / System pojedynczej bariery sterylnej · EL / Σύστημα μονού στείρου

φραγμού · KO / 단일 멸균 장벽 시스템 · ZH / 单套无菌屏障系统 · نظام

حاجز مُعقم أحادي / AR

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 / Хранить в сухом месте · PL / Chronić

przed wilgocią · EL / Να φυλάσσεται σε ξηρό μέρος · KO / 건조한 곳에

보관하십시오. · ZH / 需保存于干燥处 · يجب الحفاظ عليها جافة / AR

DE / Temperaturbegrenzung · EN / Temperature limits · FR / Li-

mitation de température · IT / Limite di temperatura · ES / Lími-

te de temperatura · PT / Limitação da temperatura · DA / Tem-

peraturbegrænsning · FI / Lämpötilarajat · NO / Temperaturbegrensing ·

HU / Hőmérsékleti tartomány · SV / Tillåtet temperaturområde · NL / Tem-

peratuurbegrenzing · HR / Ograničenje temperature · SL / Omejitev tem-

perature · CS / Omezení teploty · RO / Limitare a temperaturii · TR / Sıca-

klık sınırlaması · RU / Ограничение температуры · PL / Dopuszczalna

temperatura · EL / Όριο θερμοκρασίας · KO / 온도 제한 · ZH / 温度限值范围

حد درجة الحرارة / AR

20 °C

5

°C

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 / Не содержит

фталатов (например, DEHP) · PL / Nie zawiera ftalanów (np. DEHP) ·

EL / Δεν περιέχει φθαλικές ενώσεις (π.χ. DEHP) · KO / (디에탈헥실프탈

레이트) 포함 · ZH / 不含邻苯二甲酸盐 (DEHP) · خالٍ من مادة الفثالات / AR

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 elabo-

rado con látex natural · PT / Não fabricado com látex natural ·

DA / Ikke fremstillet med naturligt latex · FI / Ei valmistettu luonnonlatek-

sista · 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 pr-

irodnim lateksom · SL / Ni izdelano z naravnim lateksom · CS / Není vyro-

beno z přírodního latexu · RO / Nu este produs cu latex natural ·

TR / Doğal lateksle üretilmemiştir · RU / Не содержит натурального

латекса · PL / Nie zawiera lateksu kauc-zuku naturalnego · EL / Δεν

είναι κατασκευασμένο με φυσικό λάτεξ · KO / 천연 라텍스로 만들지 않

음 · ZH / 制作过程未添加天然乳胶 · غير مصنوعة من مادة اللاتكس

الطبيعية / AR

LATEX

DE / Bedingt MRT-sicher · EN / MR conditional · FR / IRM com-

patible sous conditions · IT / A compatibilità RM condizionata ·

ES / Condicional para RM · PT / Condicional para RM ·

DA / MR-betinget · FI / Soveltuu magneettikuvaukseen tietyin ehdoin ·

NO / MR-betinget · HU / MR feltételes · SV / MR-villkorlig ·

NL / MR-voorwaardelijk · HR / Uvjetno sigurno za upotrebu s MR-om · SL

/ MR pogojno · CS / MR přípustné za určitých podmínek · RO / Sigur

pentru RM în anumite condiții · TR / MR koşullu · RU / МРТ-совместимо ·

PL / Warunkowo bezpieczny w środowisku rezonansu magnetycznego ·

EL / Ασφαλές για χρήση σε περιβάλλον μαγνητικού συντονισμού υπό

προϋποθέσεις · KO / MR 조건부 · ZH / 特定条件下磁共振安全 · آمن

بشروط في مجال الرنين المغناطيسي / AR

45

DE / Bei beschädigter Verpackung nicht verwenden · EN / Do

not use device if packaging is damaged · FR / Ne pas utiliser

en cas d’emballage endommagé · IT / Non utilizzare se la con-

fezione è danneggiata · ES / No utilizar si el envase está dañado ·

PT / Não utilizar em caso de embalagem danificada · DA / Må ikke an-

vendes, 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 verpak-

king · 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 / Не использовать, если

целостность упаковки нарушена · PL / Nie używać, jeżeli opakowanie

jest uszkodzone · EL / Να μην χρησιμοποιείτε σε περίπτωση που η

συσκευασία έχει υποστεί ζημιά · KO / 포장이 손상된 경우 사용하지 마십시

오. · ZH / 如包装破损，不得使用 · منَع الاستخدام في حالة تلف العبوة / AR

DE / Ausklappbare Bildseiten · EN / Pull-out image pages ·

FR / Pages d’illustration dépliables · IT / Pagine grafiche ripie-

gabili · ES / Páginas del anverso desplegables · PT / Páginas ilustrativas

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可折叠图片页 · صفحات مصوّرة قابلة للطي / AR

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tenu de l’emballage · IT / Contenuto della confezione ·

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محتويات العبوة / AR

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Instructions for Use for

TRACOE® silcosoft® Tracheostomy Tubes for

Neonates / Infants and Children

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 tracheostomy tube. The symbols and icons

used are explained on pages 1 – 5.

1. Indications for Use / Intended Use

The TRACOE silcosoft tracheostomy tube is intended to provide direct

airway access for a tracheotomized patient up to 29 days. It may be

reprocessed for single patient use up to 7 times.

Patient population: Neonates, infants, children, and adolescents.

2. General Description

TRACOE silcosoft is a silicone tracheostomy tube which provides an

artiﬁcial airway to the lower respiratory tract for neonates, infants,

children, and adolescents.

The TRACOE silcosoft tracheostomy tube is provided in a sterile blis-

ter pack together with an obturator, a fabric neck strap and a discon-

nect wedge. The silicone tracheostomy tube is radiopaque, and wire

reinforced. It is available in different diameters and lengths, and in

cuffed or uncuffed models. The cuffed model is provided with the cuff

deﬂated and ﬂush with the tube. The obturator is made of plastic or

metal depending on the type of tube (please see Table 1 on the fold-

out pages).The appropriate diameter and length of the tube is to be

determined by the physician.

For insertion, the neck is extended with the tracheostoma open and

free of obstruction. The tracheostomy tube (with the obturator inside),

is inserted directly into the tracheostoma until the neck plate is in

contact with the skin surface. Once in place, the obturator is immedi-

ately removed and when applicable, the cuff is ﬁlled with sterile water.

With the tracheostomy tube in position it is secured in place with

a neck strap.

The TRACOE silcosoft is intended for single patient use up to 29 days

and may be reprocessed 7 times within 29 days. The frequency of

reprocessing is based on the physician’s care instructions. The device

is applicable for mechanically ventilated or spontaneously breathing

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89

patients in hospitals, pre-hospital (EMS), extended care facilities, out-

patient clinics, or home care and can be used by individuals trained in

tracheostomy care.

This product is supplied with an information card, which includes two

detachable labels with product speciﬁc details and MR imaging infor-

mation. The labels facilitate reordering and can be attached to the

patient record.

The Images 1 and 2 on the foldout pages represent

TRACOE silcosoft models (description see Table 2).

1a Plastic obturator 5b Check valve

1b Metal obturator 5c Female Luer connector

2Tube (distal end) 615 mm connector

3Neck ﬂange (plate) 7Tube (proximal extension)

4H2O Cuff 7a Connector hub (silicone)

5Inﬂation (ﬁlling) line 8Disconnect wedge

5a Pilot balloon 9Neck strap

An overview of the different types and their components is provided in

Table 1 also on the foldout pages.

Obturator:

The obturator (1) has a handle on the proximal end and a rounded,

conically shaped tip on its distal end. The obturator shape is adapted

to the tube’s inner diameter, length, and bending angle.

• The tracheostomy tube without proximal extension has a plastic

obturator (1a) with a ring handle, to assist with insertion. For correct

alignment of the obturator the display for REF-No on the ring handle

should run horizontal, see Image 4.

• The tracheostomy tube with a proximal extension has a metal

obturator with a ﬂat handle, to assist with insertion. For correct align-

ment of the obturator the arrow on the handle shows upwards and the

writing runs horizontal, see Image 5.

Tracheostomy Tube:

• The distal end (inside the patient) of the tracheostomy tube (2)

is wire reinforced, curved and features a smooth round tip.

• The tracheostomy tube includes a ﬁxed neck ﬂange (3) which

limits the insertion depth and includes eyelet holes for attachment of

the neck strap (9).

• Tracheostomy tubes without proximal extension have a silicone

hub (7a) in combination with a neck ﬂange (3). The 15 mm connector

(6) is directly attached to the silicone hub (7a).

• Tracheostomy tubes with proximal extension (7) have a

wire-reinforced tube between neck ﬂange (3) and silicone hub (7a).

The silicone hub provides a smooth, stable transition between the

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tube and the 15 mm connector.

• The 15 mm connector (6) provides a smooth surface for con-

necting the tracheostomy tube to external devices e.g. for mechanical

ventilation.

H2O Cuff Models:

• The silicone cuff (4) is inﬂated with sterile water, and located on

the distal end of the tracheostomy tube and. It is directly connected

to the inﬂation line (5), which is incorporated into the neck ﬂange (3).

• The proximal end of the inﬂation line includes a pilot balloon

(5a), an incorporated self-sealing check valve (5b), with a female Luer

connector (5c).

Disconnect Wedge:

• The plastic disconnect wedge (8) is a tool to disconnectfacili-

tate disconnection of external devices from the 15 mm connector of the

tracheostomy tube.

• The disconnect wedge slides between the female 15 mm con-

nector of the external device and the male 15 mm connector of the

tracheostomy tube to easily separate the devices, see Image 3.

Neck Strap:

• The neck strap (9) is a soft strip of padded fabric that wraps

around the patient’s neck.

• The ends of the strap include hook and loop fasteners that are

inserted through the eyelet holes of the neck ﬂange (3) to secure the

tracheostomy tube position.

3. MRI Safety Information

Non-clinical testing has demonstrated the TRACOE silcosoft tracheos-

tomy tube is MR Conditional. A patient with this device can be safely

scanned in an MR system meeting the following conditions:

• Static magnetic ﬁeld of 1.5 Tesla (T) or 3.0 Tesla (T).

• Maximum spatial ﬁeld gradient of 1900 gauss/cm (19 T/m).

• Maximum MR system reported, whole body averaged speciﬁc

absorption rate (SAR) of 2 W/kg and a maximum whole head speciﬁc

absorption rate (SAR) of 3.2 W/kg

• Quadrature driven transmit body coil only.

• The neck ﬂange (3) must be secured in place with the neck

strap (9).

• For tubes with H2O Cuff only: The check valve (5b) must be

secured to the skin with medical tape, away from the area of MR diag-

nostic interest.

In non-clinical testing, the image artifact caused by the tube extends

(radially) up to 19 mm from the TRACOE silcosoft tracheostomy tube

(non-cuffed) when imaged with a gradient echo pulse sequence and

a 1.5T MR system, and up to 28 mm when imaged with a spin echo

pulse sequence in a 3.0T MR system.

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Tubes with H2O Cuff: In non-clinical testing, the image artifact, caused

by the check valve, extends (radially) up to 107 mm from the check

valve when imaged with a gradient echo pulse sequence and a 1.5T

MR system, and up to 113 mm when imaged with a spin echo pulse

sequence in a 3.0T MR system. Therefore, when MR imaging a tube

with the H2O Cuff, it is recommended to tape the check valve to the

patient’s skin away from the area of interest.

Warning:

When used in MR Imaging:

• Securely fasten the tube, with the neck strap, to prevent possi-

ble movement while in the MR environment.

• Securely afﬁx the check valve (5b) away from the area of inter-

est with standard medical tape to prevent movement within the MR

environment.

• MR image quality may be compromised if the area of interest is

close to the position of the tube and/or inﬂation valve.

4. Contraindications

• The TRACOE silcosoft tracheostomy tube cannot be used in

conjunction with heat emitting devices, e.g. lasers to prevent the tube

material from being damaged.

• The H2O Cuff should not be inﬂated, when a speaking valve is

used and vice versa.

5. General Precautions

• A spare tracheostomy tube should remain at the patient’s bed-

side and available for replacement, as required. This device should be

clean and dry.

• Ensure that an alternative airway is always available.

• The disconnect wedge (supplied with the device) should remain

at the patient’s bedside and be available to assist in the disconnection

of external devices, e.g. mechanical ventilation.

• The sterile packaging should be inspected for damage prior to

opening. If the packaging is damaged the device should not be used.

• The tracheostomy tube should be inspected for tube integrity

and function prior to use/insertion. Verify that the tube is free of

obstruction, H2O Cuff material is not brittle or torn and can be inﬂated/

deﬂated, absence of kinks, tears or cuts, stable connection between

the tube and the neck ﬂange, etc. If the product is damaged, it should

be discarded and replaced with a new product.

• Do not use unnecessary force on the tracheostomy tube when

connecting to, or disconnecting from, external devices. This may result

in damage to the tracheostomy tube, decannulation and/or increased

air resistance. Always hold the tracheostomy tube at the base of the

15 mm connector (6) when disconnecting from external devices. If

external devices are tightly ﬁxed, use the disconnect wedge (9) to

separate them from the 15 mm connector tube.

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• When the tracheostomy tube is used together with other medi-

cal devices, please acknowledge their instructions for use. Contact the

manufacturer if there are any questions or assistance required.

• The use of tracheostomy tubes can lead to pressure points and

skin irritation (e.g. due to moisture). To avoid this place a dressing

underneath the neck ﬂange.

• Ensure that the syringe for ﬁlling the H2O Cuff is clean and free

of contaminants. The syringe must be removed immediately after use.

Failure to do so may result in a deﬂation of the H2O Cuff ﬁlling system

which will reduce efﬁcient ventilation or protection from aspiration.

• To avoid damage to the H2O Cuff and improve ease of inser-

tion, always ensure that the H2O Cuff is completely deﬂated prior to

insertion.

• To avoid damage to the H2O Cuff material it should not be in

contact with lidocaine-containing aerosols or ointments.

• When repositioning the patient, ensure that the patient does not

squeeze the pilot balloon (5a). This can increase the cuff pressure and

therefore harm the trachea.

• Prolonged storage of the tube after reprocessing can increase

the risk of bacterial contamination.

• For appropriate handling of the tracheostomy tube follow the

standard guidelines for prevention of infection as stipulated by the

Center for Disease Control and Prevention (USA), the Robert Koch

Institut (DE), or the local or national authority.

6. Warnings

• Do not use, if the sterile packaging has been compromised/

damaged, e.g. open edges, holes in packaging etc.

• Improper storage conditions may result in tube damage or con-

tamination.

• Use only water-soluble lubricating gel.

• To prevent an increase in air resistance, ensure that the tube

does not become obstructed when applying lubricating gel to the

obturator tip.

• Check the position and function of the tube following insertion.

Incorrect placement may result in permanent damage to the tracheal

mucosa or increased air resistance.

• Do not move or shift the tube once it is in position, as this may

damage the stoma / trachea or lead to insufﬁcient ventilation.

• A subtle increase in air resistance is possible, if the tube is not

suctioned regularly.

• Use only suction catheters to clear the secretions from the

patient’s respiratory tract and the tracheostomy tube. Instruments with

a conical tip may wedge in the tube and restrict ventilation.

• If the suction catheter gets stuck in the tracheostomy tube rotate

the catheter.

• Regularly check that all connections are secure to prevent an

inadvertent disconnection of the tube from external equipment and

ensure efﬁcient ventilation.

12 13

• Only ﬁll the H2O Cuff with sterile water. Do not ﬁll the H2O Cuff

with air as this would impair the sealing function of the cuff which may

result in aspiration or VAP (ventilator associated pneumonia).

• The H2O Cuff is an HPLV (high pressure low volume) cuff there-

fore, the measured cuff pressure is not related to the actual cuff pres-

sure exerted on the tracheal wall.

• Before deﬂating the H2O Cuff (removal of sterile water), ensure

that the patient’s upper respiratory tract is unobstructed. When appli-

cable, clear the upper respiratory tract of any secretions through suc-

tion and if possible patient coughing.

• Do not overﬁll the H2O Cuff, as this poses a risk of permanent

damage to the trachea.

• Insufﬁcient ﬁlling of the H2O Cuff could result in an increased

risk of aspiration or VAP (ventilator associated pneumonia).

• If the cuff leaks during use, replace the tube and contact

TRACOE Customer Service.

• To prevent damage to the stoma or trachea, ensure that the H2O

Cuff is completely deﬂated (empty) prior to insertion or removal of the

tube (see chapter 8). If it is not possible to deﬂate the cuff, cut the

inﬂation line with a pair of scissors and drain the liquid. With this event,

the product is defective and must be replaced.

• Additional proximal extension pieces, i.e. TRACOE kids exten-

sion piece REF 356 are not allowed to be used in combination with an

proximal extended TRACOE silcosoft tube (REF 361, REF 363, REF

371, REF 373).

7. Adverse Reactions

Typical adverse effects during usage of tracheostomy tubes include

pressure points, stenosis, skin irritation, a need to cough, and swal-

lowing difﬁculties.

Irritation, a need to cough or bleeding may also occur during insertion

and removal of the tube. In the event of an adverse effect, please con-

tact a medical professional immediately.

8. Functional Description

8.1 Preparing the Tube

Note: If the tube fails any step of inspection, repeat the procedure with

a new TRACOE silcosoft tracheostomy tube. Keep the tube with the

batch number when contacting TRACOE Customer Service.

The following functions must be checked immediately prior to use:

• Inspect the sterile packaging to ensure it is secure, undam-

aged and all components are present.

• Open the package and inspect the device for damage prior to

use.

• Ensure the obturator can be easily moved in and out of the tube.

• Ensure the envisaged suction catheter is of appropriate size and

can be easily inserted through the tube.

• If obturator or suction catheter can not be moved easily, please

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ad some water-soluble lubricant gel to the tip of the obturator or

catheter.

If the device fails the initial inspection, discard and repeat the proce-

dure with a new device.

Additional inspection requirements for tubes with H2O Cuff: Inspect

the pilot balloon prior to use and perform a H2O Cuff-ﬁlling test to

ensure that the cuff is leak-proof and ﬁlls uniformly.

H2O Cuff-ﬁlling test: Use a sterile syringe (0 – 10 ml) with ml scale. Fill

the syringe with sterile water and connect it to the female Luer con-

nector (5c) of the ﬁlling tube (check valve). Press the plunger of the

syringe and ﬁll the H2O Cuff with 2 ml (maximum) of liquid. Inspect the

balloon to ensure it is leak proof and ﬁlls uniformly.

When the inspection is complete, remove the sterile water from the cuff,

by pulling back the syringe plunger. Once all the water is removed the

tube (with deﬂated cuff) is ready for insertion, see chapter 8.4.

Warning:

• If the H2O Cuff leaks, do not use the tube.

• If the H2O Cuff cannot be ﬁlled or adheres (“sticks”) to the tra-

cheostomy tube, carefully press the cuff between thumb and foreﬁnger

to separate it from the tube, then repeat the ﬁlling procedure. If this

procedure has no effect, do not use the tube.

8.2 Preparing the patient

Ensure that the patient is optimally pre-oxygenated before insertion or

re-insertion. To facilitate insertion, slightly overextend the patient’s

neck, if possible.

Should complications arise during insertion or re-insertion, appropri-

ate safety measures should be taken (e.g. keep on hand a tracheal

dilator or a tube with a smaller diameter).

8.3 Inserting the tube

Prior to insertion, verify that the obturator tip has not been inadvert-

ently pushed inside the distal end of the tube. This can be avoided by

simultaneously holding the tube and obturator with one hand.

With the obturator properly inserted into the tube, apply a pea-sized

amount of water-soluble lubricating gel on the tip without blocking the

tube opening.

Extend the patient’s neck, and with the stoma clear, insert the tube

and obturator (with lubricated tip), into the patient’s stoma until the

neck ﬂange is in contact with the skin surface. Immediately pull the

obturator out of the tube to open the airway through the tube.

8.4 Following Tube Insertion

Secure the tube with the neck strap by attaching one end of the neck

strap (9) through the opening on the neck ﬂange (3) and wrapping the

strap around the patient’s neck, attaching the opposite end of the neck

strap through the opposite neck ﬂange opening. Ensure that the strap is

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14 15

tight, and the tube is secured to prevent movement during clinical use.

For tracheostomy tubes with H2O Cuff:

• When the tube is secured, ﬁll the H2O Cuff with sterile water

through the pilot valve, using a syringe.

• Fill the syringe with 5 ml of sterile water.

• Use either the minimal leak technique or minimal occlusive vol-

ume technique when ﬁlling the cuff, to ensure appropriate tra-

cheal seal.

• Record the individual patient-related volume used to ﬁll the

H2O Cuff.

• Verify the position and function (see chapter 6 Warnings) of the

tube. Do not adjust the tube position when the H2O Cuff is

ﬁlled, as this may damage the stoma and/or tracheal mucosa.

8.5 Connecting/Disconnecting External Equipment

To connect to external equipment (e.g. mechanical respirator):

Firmly hold the base of the 15 mm connector and gently twist the con-

nection end of the external device until it is securely attached to the

tracheostomy tube. If in doubt, twist the connection end on and off

several times, in order to conﬁrm the amount of force needed to

ensure the connection is secure and the external device can be easily

disconnected at a later time.

When disconnection of the external device is difﬁcult, use the discon-

nect wedge. Slide the opening of the disconnect wedge between the

15 mm connector and external device until the two devices separate

(see Image 3).

8.6 Deﬂating the H2O Cuff

Before deﬂating the cuff, ensure that secretions cannot enter the lower

respiratory tract.

Attach a syringe (with the plunger pushed in) to the female Luer con-

nector (5c). When attached, pull the plunger back until all liquid is

removed from the cuff. The H2O Cuff must be completely deﬂated

(empty) prior to removal.

8.7 Removing the Tube

• Disconnect the neck strap from the neck ﬂange.

• Slightly overextend the patient’s neck, if possible.

• For tubes with H2O Cuff, ensure the cuff is completely empty

of liquid.

• Firmly hold the base of the 15 mm connector and gently pull the

tracheostomy tube from the stoma.

• Following removal, the tube should be cleaned as soon as pos-

sible to prevent encrustation of ﬂuids.

• If the product is damaged, do not reuse the tube and inform

TRACOE Customer Service.

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