COOK Medical Echotip User manual

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IFU0051-8
EchoTip® Ultra Endobronchial HD Ultrasound Needle for Olympus Scopes
Instructions for Use
Ендобронхиална ултразвукова игла с висока разделителна способност EchoTip®
Ultra за ендоскопи Olympus
Инструкции за употреба
Endobronchiální jehla EchoTip® Ultra pro ultrazvuk s vysokým rozlišením, pro
endoskopy Olympus
Návod k použití
EchoTip® Ultra endobronkial HD ultralydsnål til Olympus skoper
Brugsanvisning
EchoTip® Ultra endobronchiale HD ultrasone naald voor Olympus endoscopen
Gebruiksaanwijzing
Endobronhiaalne kõrglahutusega ultrahelinõel EchoTip® Ultra endoskoopidele
Olympus
Kasutusjuhised
Aiguille ultrasonore HD endobronchique EchoTip® Ultra pour les endoscopes Olympus
Mode d’emploi
EchoTip® Ultra endobronchiale HD-Ultraschallnadel für Olympus-Endoskope
Gebrauchsanweisung
Ενδοβρογχική βελόνα υπερήχων υψηλής ανάλυσης EchoTip® Ultra για ενδοσκόπια
Olympus
Οδηγίες χρήσης
EchoTip® Ultra endobronchialis, nagy felbontású, echogén tű Olympus
endoszkópokhoz
Használati utasítás
Ago ecografico endobronchiale ad alta definizione EchoTip® Ultra per endoscopi
Olympus
Istruzioni per l'uso
EchoTip® Ultra endobronhiālā augstas precizitātes ultraskaņas adata
Olympus endoskopiem
Lietošanas instrukcija
„EchoTip® Ultra“ endobronchinio didelės skiriamosios gebos ultragarso adata, skirta
naudoti su„Olympus“ endoskopais
Naudojimo nurodymai
EchoTip® Ultra endobronkial HD-ultralydnål for Olympus-skop
Bruksanvisning
Igła EchoTip® Ultra do ultrasonografii wewnątrzoskrzelowej o wysokiej rozdzielczości
do endoskopów Olympus
Instrukcja użycia
Agulha de ultrassons endobrônquica EchoTip® Ultra de alta definição para
endoscópios Olympus
Instruções de utilização
Ac ecografic HD endobronșic EchoTip® Ultra pentru endoscoape Olympus
Instrucțiuni de utilizare
Endobronchiálna ultrazvuková ihla svysokým rozlíšením EchoTip® Ultra
preendoskopy Olympus
Návod na použitie
Aguja de ecografía endobronquial de alta definición
EchoTip® Ultra para endoscopios Olympus
Instrucciones de uso
EchoTip® Ultra endobronkial HD ultraljudsnål för
Olympus endoskop
Bruksanvisning
EN
9
BG
13
CS
18
DA
22
NL
26
ET
31
FR
35
DE
40
EL
45
HU
50
IT
55
LV
60
LT
64
NO
68
PL
72
PT
77
RO
82
SK
86
ES
90
SV
95 *IFU0051-8*

3
Biopsy Port Seal
Locking Clip
Luer Connector
Adaptor Base
Adaptor Top
Biopsy Port Seal
Уплътнение на отвора за биопсия
Těsnění bioptického portu
Forsegling på biopsiport
Afsluiting biopsiepoort
Biopsiapordi tihend
Capuchon étanche de l’orice pour biopsie
Abdichtung des Biopsieanschlusses
Στεγανωτικό παρέμβυσμα θύρας βιοψίας
Biopszianyílás tömítése
Guarnizione del raccordo per biopsia
Biopsijas pieslēgvietas blīve
Biopsijos angos uždoris
Biopsiportforsegling
Uszczelka portu biopsji
Vedante do orifício de biopsia
Sigiliul portului de biopsie
Uzáver bioptického portu
Junta del acceso de biopsia
Biopsiportstätning
Luer Connector
Конектор тип Luer
Konektor Luer
Luer-konnektor
Luer-connector
Luer-tüüpi ühendus
Connecteur Luer
Luer-Anschluss
Συνδετικό Luer
Luer-csatlakozó
Connettore Luer
Luer tipa savienotājs
Luerio jungtis
Luer-kobling
Łącznik Luer
Conector Luer
Conector Luer
Luerov konektor
Conector Luer
Luer-anslutning
Locking Clip
Блокиращ клипс
Aretovací svorka
Låseklemme
Borgclip
Kinnitusklamber
Pince de verrouillage
Arretierclip
Κλιπ ασφάλισης
Rögzítőkapocs
Clip di bloccaggio
Noslēgskava
Fiksuojamasis spaustukas
Låseklips
Zacisk blokujący
Grampo de xação
Clemă blocantă
Poistná objímka
Abrazadera de jación
Låsklämma
Adapter Top
Горна част на адаптера
Horní strana adaptéru
Øverste del af adapter
Adaptertop
Adapteri ülemine osa
Haut de l’adaptateur
Oberteil des Adapters
Κορυφή του προσαρμογέα
Adapter teteje
Sommità dell’adattatore
Adaptera augšdaļa
Adapterio viršus
Adaptertopp
Część górna łącznika
Parte de cima do adaptador
Capacul adaptorului
Vrch adaptéra
Parte superior del adaptador
Adapterns övre del
Adapter Base
Долна част (основа) на адаптера
Základna adaptéru
Nederste del af adapter
Adapterbasis
Adapteri alumine osa
Base de l’adaptateur
Unterteil des Adapters
Βάση του προσαρμογέα
Adapter alapja
Base dell’adattatore
Adaptera pamatne
Adapterio pagrindas
Adapterbase
Podstawa łącznika
Base do adaptador
Baza adaptorului
Podstavec adaptéra
Base del adaptador
Adapterns bas
Fig.1

4
Fig.3
Fig.2

5
2 4 6 8
10 ml
Stopcock “open”Plunger
Plunger
Бутало
Píst
Stempel
Plunjer
Kolb
Piston
Kolben
Έμβολο
Dugattyú
Stantuo
Virzulis
Stūmoklis
Stempel
Tłoczek
Êmbolo
Piston
Piest
Émbolo
Kolv
Stopcock“open”
Кранче“отворено”
„Otevřený“ uzavírací kohout
Stophane“åben”
Afsluitkraan‘open’
Sulgemisventiil avatud
Robinet ouvert
Absperrhahn geönet
Στρόφιγγα ανοικτή
Elzárócsap nyitott állásban
Rubinetto aperto
Slēgkrāns atvērts
Kranelis„atviras“
Stoppekran åpen
Kranik w pozycji otwartej
Torneira de passagem“aberta”
Robinet„deschis”
Otvorený kohútik
Llave de paso «abierta»
Kran ”öppen”
Fig.4

6
Fig.5

7
Needle Handle
Sliding Sheath Adjuster
Safety RingSheath
Reference Mark
Stylet Hub
Fig.6
Sliding Sheath Adjuster
Плъзгащ се регулатор на защитната обвивка
Posuvné nastavovací zařízení sheathu
Glidende sheath-justering
Schuifregeling van de sheath
Liughülsi regulaator
Ajusteur de gaine coulissant
Verschiebbarer Schleuseneinsteller
Συρόμενος προσαρμογέας θηκαριού
Elcsúsztatható hüvelyhossz-beállító
Regolatore scorrevole della guaina
Pārbīdāmais ievadapvalka regulētājs
Slankusis vamzdelio reguliatorius
Glidende hylsejusteringsmekanisme
Przesuwany regulator koszulki
Regulador deslizante da bainha
Ajustor glisant al tecii
Posuvný nastavovač puzdra
Ajustador deslizante de la vaina
Glidande hylsjusterare
Sheath Reference Mark
Означение за дължината на защитната обвивка
Referenční značka sheathu
Referencemærke på sheath
Referentiemarkering van de sheath
Hülsi tähis
Repère de référence sur la gaine
Schleusenbezugsmarke
Σήμανση αναφοράς θηκαριού
Hüvelyhossz referenciajele
Indicatore di riferimento della guaina
Ievadapvalka atskaites atzīme
Vamzdelio atskaitos žymė
Referansemerke på hylsen
Znacznik referencyjny wysunięcia koszulki
Marca de referência da bainha
Marcaj de referință al tecii
Referenčná značka puzdra
Marca de referencia de la vaina
Hylsans referensmarkering
Needle Handle
Дръжка на иглата
Rukojeť jehly
Nålegreb
Naaldhandvat
Nõela käepide
Poignée de l’aiguille
Nadelgri
Λαβή βελόνας
Tű fogantyúja
Impugnatura dell’ago
Adatas rokturis
Adatos kotelis
Nålehåndtak
Uchwyt igły
Punho da agulha
Mânerul acului
Rukoväť ihly
Mango de la aguja
Nålhandtag
Safety Ring
Предпазен пръстен
Pojistný prstenec
Sikkerhedsring
Veiligheidsring
Kaitserõngas
Bague de sécurité
Sicherheitsring
Δακτύλιος ασφαλείας
Biztonsági gyűrű
Anello di sicurezza
Drošības gredzens
Apsauginis žiedas
Sikkerhetsring
Pierścień bezpieczeństwa
Anel de segurança
Inel de siguranță
Bezpečnostný krúžok
Anillo de seguridad
Säkerhetslåsring
Stylet Hub
Втулка на стилето
Nástavec stiletu
Stiletmue
Aanzetstuk van het stilet
Stiletikinnitus
Embase du stylet
Mandrinansatz
Ομφαλός του στειλεού
Mandrin végidoma
Pomello del mandrino
Stiletes galviņa
Zondo kaištis
Stilettfeste
Głowica mandrynu
Conector do estilete
Acoperitoarea stiletului
Hrdlo styletu
Conector del estilete
Mandrängfattning

8
Needle HandleSliding Sheath Adjuster
Safety RingSheath
Reference Mark
Stylet Hub
Needle HandleSliding Sheath Adjuster
Safety RingSheath
Reference Mark
Stylet Hub
Fig.7

9
ENGLISH
ECHOTIP® ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FOR
OLYMPUS SCOPES
CAUTION: U.S. Federal Law restricts this device to sale by or on the order
of a physician.
INTENDED USE
This device is used to sample targeted submucosal and extramural lesions
within or adjacent to the tracheobronchial tree or gastrointestinal tract through
the accessory channel of an ultrasound endoscope for Fine Needle Aspiration
(FNA).
DEVICE DESCRIPTION
The device consists of a handle with adjustable components to allow the user
to adjust the extension of the needle and sheath. The device has a 4.1 Fr outer
sheath for protection of the needle and the scope, and it is attached to the
accessory channel of an Olympus endobronchial ultrasound (EBUS) scope using
an adapter. The device has a maximum needle extension length of 5cm and
sheath adjustment length of 3cm. The device is supplied with a 10 ml syringe
to utilize the standard vacuum technique for sample collection, if desired, and
an accessory channel adapter. The device is available in two different needle
sizes: 22 and 25ga.
CONTRAINDICATIONS
Contraindications include those specific to the primary endoscopic ultrasound
procedure to be performed in gaining access to the desired position to visualize
the targeted site.
Relative contraindications include, but are not limited to: coagulopathy.
POTENTIAL ADVERSE EVENTS
Potential adverse events associated with bronchial endoscopy and
gastrointestinal endoscopy include, but are not limited to: allergic reaction to
medication, allergic reaction to nickel, aspiration, cardiac arrhythmia or arrest,
damage to blood vessels, death, discomfort, fever, hemorrhage, hypotension,
infection, inflammation, nerve damage, pain, perforation, pneumoperitoneum,
respiratory depression or arrest, sepsis, septicemia/bacteremia and
tumorseeding.
WARNINGS
Not for use in the heart or vascular system.
The tip of the needle and stylet are sharp and could cause injury to the patient
or user if not used with caution.

10
This device is designed for single use only. Attempts to reprocess, resterilize,
and/or reuse may lead to device failure and/or transmission of disease.
If the package is opened or damaged when received, do not use. Visually
inspect with particular attention to kinks, bends and breaks. If an abnormality
is detected that would prohibit proper working condition, do not use. Please
notify Cook Medical for return authorization.
PRECAUTIONS
Refer to package label for minimum channel size required for this device.
The needle must be retracted into the sheath and the thumbscrew on the
safety ring must be locked at the 0cm mark to hold the needle in place prior
to introduction, advancement or withdrawal of the device. Failure to retract the
needle may result in damage to the scope.
Ensure the stylet is fully inserted when advancing the needle into the
targetsite.
Do not use this device for any purpose other than stated intended use.
Use of this device is restricted to a trained healthcare professional (Rxonly).
When targeting multiple sites, adequate care should be taken to minimize the
risk of tumor seeding.
This device is intended for use with an Olympus EBUS scope.
PLACEMENT OF ACCESSORY CHANNEL ADAPTER Illustrations
1. Examine the adapter and note features (Fig.1).
2. Place the adapter, in the open position, in line with the scope accessory
channel metal hub.
3. Slide the adapter on to the accessory channel ensuring that the base of the
adapter slides under the accessory channel metal hub (Fig.2).
4. Close the adapter ensuring it is locked (Fig.3).
5. The adapter will now function as a Luer lock to which the needle can be
connected. Note: If irrigation of accessory channel is desired/necessary, irrigate
through closed adapter prior to insertion or after removal of needle.
SYSTEM PREPARATION
1. Examine syringe. It has two plunger locks that must be depressed to advance
plunger. The tip of the syringe has a Luer lock fitting with a stopcock on the
side port. Air can be exchanged when the stopcock is in“open”position, aligned
with syringe (Fig.4).
2. Prepare syringe as follows:
a) With stopcock in“open”position, depress plunger locks and fully advance
plunger into syringe.
b) Turn stopcock to “closed”position.
c) Pull plunger back until it is locked into place at desired setting, creating
a vacuum.
d) Set prepared syringe aside until aspiration is required.