Tracoe 580 User manual

Instructions for
TRACOE® Silicone Short Tubes
REF 580, REF 581, REF 582,
REF 583, REF 585, REF 586
Gebrauchsanweisung für
TRACOE® Silikonkurzkanülen
REF 580, REF 581, REF 582,
REF 583, REF 585, REF 586
TRACOE medical GmbH
Reichelsheimer Straße 1 / 3, 55268 Nieder-Olm / Germany
Tel.: [phone], Fax: [phone]
[email protected], www.tracoe.com
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EN / Warning. Please read Instructions for Use · DE / Ach-
tung. Gebrauchsanweisung beachten · FR / Attention.
Respecter le mode d’emploi · IT / Attenzione. Consultare le is-
truzioni 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 · NB / 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 upora-
bu · EL / · KO /
· ZH / · · / A R
EN / For single patient use only ·DE / Nur für einen Patienten ·FR /
Pour un seul patient ·IT / Prodotto destinato ad un solo paziente ·ES
/ Sólo para un paciente ·PT / Só para um paciente ·DA / Må kun
brugges til én patient ·FI / Vain yhden potilaan käyttöön ·NB / Kun
for én pasient ·HU / Csak egy betegnél alkalmazható ·SV / Endast
för en patient ·NL / Slechts voor één patiënt bestemd · HR / Samo
za jednog pacijenta · EL / · KO /
· ZH / / AR
EN / Item number · DE / Artikelnummer · FR / Référence ·
IT / Codice prodotto · ES / Número de artículo · PT / Número
do artigo · DA / Artikelnummer · FI / Tuotenumero · NB / Artikkelnum-
mer · HU / Cikkszám · SV / Katalognummer · NL / Artikelnummer · HR
/ Broj artikla · · KO / · ZH / · · / AR
EN / Batch code · DE / Chargencode · FR / Code de lot
· IT / Numero di lotto · ES / Código de lote · PT / Códi-
go do lote · DA / Batchkode · FI / Eräkoodi · NB / Chargekode ·
HU / Tételkód · SV / Satsnummer · NL / Lotcode · HR / Oznaka serije ·
EL / · KO / · ZH / · / 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
EN / Date of manufacture · DE / Herstellungsdatum · FR / Date
de fabrication · IT / Data di produzione · ES / Fecha de fabri-
cación · PT / Data de fabricação · DA / Produktionsdato · FI /
Valmistuspäivä · NB / Produksjonsdato · HU / Gyártási dátum · SV / Till-
verkningsdatum · NL / Fabricagedatum · HR / Datum proizvodnje · EL /
· KO / · ZH / · / AR

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EN / Use by date · DE / Verwendbar bis · FR / Utilisable jusqu’au
· IT / Utilizzare entro il · ES / Fecha de caducidad · PT / Utilizá-
vel até · DA / Anvendes inden · FI / Käytettävä ennen · NB / Kan
brukes til · HU / Felhasználhatóság dátuma · SV / Används före–ut-
gångsdatum · NL / Bruikbaar tot · HR / Upotrijebiti do · EL / ·
KO / · ZH / · / AR
EN / Not made with natural rubber latex · DE / Nicht mit
natürlichem Latex hergestellt · 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
· NB / Ikke produsert med naturlig latex · HU / Nem természetes latexb„l
készült · SV / Tillverkad utan användning av naturlig latex · NL / Niet
gefabriceerd met natuurlijk latex · HR / Nije proizvedeno s prirodnim
lateksom · EL / Δεν είναι κατασκευασμένο με φυσικό λάτεξ ·
KO / 천연 라텍스를 포함 하거나 들어 있음 · ZH / 制作过程未添加天然乳胶 ·
/ AR
EN / Not made with phthalates (e.g. DEHP) · DE / Phthalat
nicht enthalten (z.B. 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) · NB / 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) · EL / Δεν περιέχει φθαλικές ενώσεις (π.χ. DEHP) · KO / (
디에탈헥실프탈레이트) 포함 · ZH / 不含邻苯二甲酸盐 (DEHP) ·
/ AR

Instructions for
TRACOE®Silicone Short Tubes
TRACOE® Silicone Short Tubes with connector, 36 mm,
REF 580
TRACOE® Silicone Short Tubes with connector, fenestrated, 36 mm,
REF 581
TRACOE® Silicone Short Tubes with connector, 53 mm,
REF 582
TRACOE® Silicone Short Tubes with connector, fenestrated, 53 mm,
REF 583
TRACOE® Silicone Short Tubes, 36 mm,
REF 585
TRACOE® Silicone Short Tubes, 53 mm,
REF 586
1. General Information
CAUTION: The following instructions are meant as information for
physicians, healthcare personnel and patients. Before using the
products, they have to be read carefully. These instructions refer
exclusively to the above mentioned and below described products.
healthcare personnel in charge must be familiar with these instructions.
CAUTION: The tubes are not sterile; however, they were produced
and packed in a clean room.
Single-Patient Product: The TRACOE® Silicone Short Tubes are
medical products intended for only one patient. Multiple use on one
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TRACOE medical GmbH
Reichelsheimer Straße 1 / 3, 55268 Nieder-Olm / Germany
Tel.: [phone], Fax: [phone]
[email protected], www.tracoe.com

and the same patient is allowed. It is recommended to always keep a
tube for replacement handy.
Useful Life: 29 days. Make sure that the
- inner cannula of the tube is free from obstruction
- the tube does not show signs of damage
If maintained well, tubes can be used for up to 6 months. After that, the
tube should be replaced by a new tube. The alternating use of several
tubes does not extend the useful life of the individual tube.
CAUTION: Federal law (USA) restricts the products to sale by or on
the order of a physician.
Packaging Contents: Each packaging contains a tube, a neck strap,
an instruction for use, and a patient information card. On this info card,
there are two detachable labels, on which you can find all details
of the product (REF No., size, length, lot number). The information card
should be kept separately. It makes reordering easier and should be
enclosed in any complaint. The detachable label may be applied, for
example, to the patient’s record.
Sizes/Dimensions: All tubes can be supplied in sizes 08, 09, 10, and
12, and are available with a length of 36 or 53 mm (see Fig. 1 and
Fig. 2 as well as Order Information).
Storage: The products must be stored in a cool and dry location.
Temporary storage for ≤ 30 days at ≤ +50 °C is possible. Protect the
product from sunlight and extreme cold.
Parts/Disposal: The TRACOE® Silicone Short Tubes consist of
high-quality silicone, which is internationally authorised for medical
use. All products are free of latex. Disposal of the products may only
be performed in accordance with the valid national regulations for
waste materials.
2. Product Description
General Characteristics
TRACOE® Silicone Short Tubes respectively consist of a flexible tube
with a neck flange. They do not include an obturator. The tubes are
bent at an angle of 62 degrees. All Silicone Short Tubes show two
openings at the neck flange for fixation by means of a neck strap.
The tubes REF 580, REF 581, REF 582, and REF 583 provide an
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