Atos Tracoe Kids Silcosoft Kullanma talimatları

Tip
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
1b
4
2
3
7
7a
6
5c
5b
5a
5
1b
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
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
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
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
· 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
· 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
°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
· 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
desdobráveis · DA / Billedsider, der kan foldes ud · FI / Avattavat kuvasivu ·
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stranice sa slikama · SL / Zložljive strani s slikami · CS / Výklopné stránky
s obrázky · RO / Pagini pliante cu ilustraţii · TR / Açılabilen resimli sayfalar ·
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可折叠图片页 · صفحات مصوّرة قابلة للطي / AR
DE / Packungsinhalt · EN / Packaging Content · FR / Con-
tenu de l’emballage · IT / Contenuto della confezione ·
ES / Contenido del envase · PT / Conteúdo da embalagem ·
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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 ·
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محتويات العبوة / AR
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89
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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10 11
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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14 15
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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Atos Tracoe Kids Silcosoft Kullanma talimatları

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Kullanma talimatları