ivascular Oceanus 35 User manual

oceanus
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BALLOON CATHETER FOR PERIPHERAL PREDILATION
FOR 0.035” GUIDE WIRE. INSTRUCTIONS FOR USE .......................... 3
CATÉTER BALÓN DE PREDILATACIÓN PERIFÉRICO PARA
GUÍA DE ALAMBRE DE 0.035”. INSTRUCCIONES DE USO ................ 7
CATETER BALÃO DE PRÉ-DILATAÇÃO PERIFÉRICO PARA
FIO-GUIA DE 0.035”. INSTRUÇÕES DE UTILIZAÇÃO ......................... 11
CATETERE A PALLONCINO PERIFERICO DI PRE-DILATAZIONE
PER FILO GUIDA DI 0,035”. ISTRUZIONI D’USO ............................... 15
CATHÉTER BALLONNET DE PRÉ-DILATATION PÉRIPHÉRIQUE
POUR GUIDE EN FIL MÉTALLIQUE DE 0,035’’ MODE D’EMPLOI ...... 19
BALLONKATHETER FÜR PERIPHERE VORDILATATION FÜR 0,035”
FÜHRUNGSDRAHT. GERBRAUCHSHINWEISE ................................... 23
БАЛЛОННЫЙ КАТЕТЕР ДЛЯ ПРЕДИЛАТАЦИИ ПЕРИФЕРИ-
ЧЕСКИХ СОСУДОВ ДЛЯ ПРОВОДНИКА 0,035”. ИНСТРУКЦИИ
ПО ИСПОЛЬЗОВАНИЮ ................................................................... 27
BALÓNKOVÝ KATÉTR PRO PERIFERNÍ PREDILATACI S VODICÍM
DRÁTEM 0,035”. NÁVOD K POUŽITÍ ................................................. 31
ΚΑΘΕΤΗΡΑΣ ΜΕ ΜΠΑΛΟΝΙ ΓΙΑ ΠΡΟΔΙΑΣΤΟΛΗ ΠΕΡΙΦΕΡΙΚΩΝ
ΑΡΤΗΡΙΩΝ ΓΙΑ ΣΥΡΜΑΤΙΝΟ ΟΔΗΓΟ 0,035 ιν. ΟΔΗΓΙΕΣ ΧΡΗΣΗΣ ....... 35
CEWNIK BALONOWY DO PREDYLATACJI NACZYŃ OBWODOWYCH
DO PROWADNIKÓW 0,035 cala. INSTRUKCJA UŻYTKOWANIA ......... 39

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1. Descripon of the Product
The balloon catheter is a dual lumen catheter from the connector to the p, also known as OTW, designed
for percutaneous transluminal angioplasty of peripheral arteries.
The catheter has two lumens body from the connector to the p.
On the distal part of the catheter, before the p, is located the balloon or inatable segment to dierent
pressures. The balloon dilates the artery when is inated by means of infusion of contrast liquid inside it.
The connector is Y-shaped, with two ports:
-The side port allows contrast liquid passage to dilate the balloon.
-The straight port intended for guide wire inseron. The guide wire is inserted into the connector port
and comes out of the p of the catheter to reach the lesion.
There is likewise a lumen through which the guide wire runs and a lumen through which contrast liquid
enters the balloon, directly connected to each of the ports in the luer or connector.
The maximum diameter of the guide wire must not exceed 0.89mm = 0.035 inches.
The useful length of the catheter is 80cm or 140cm depending on the item reference.
The balloon is supplied in the following lengths and diameters:
BALLOON DIAMETERS (mm)
3456789 10 12
BALLOON LENGHT
(mm)
20 XXXXXXXXX
40 XXXXXXXXX
60 XXXXXXXXX
80 XXXXXXX
120 X X X X X
150 X X X X
200 X X X X
The balloon is intended to reach dierent diameters at dierent pressures (according to the compliance
curve shown on the primary packaging).
To inate the balloon, the connector inaon port must be connected to an inaon device. The balloon is
inated to predictable diameters with the pressure shown by the manometer. Two radiopaque markers are
located at each end of the balloon in order to mark its length and help the user to see the catheter while
inside the paent.
At the distal end is the p, which is rounded and atraumac in shape in order to avoid damaging the arteries
while it is being advanced.
Contents
-One OTW catheter covered by protection sheath for the balloon, inserted into a dispenser in a
sterile bag.
-One card with the compliance curve showing the nominal inaon pressure and the recommended
maximum pressure.
-One leaet with instrucons for use.
2. Indicaons
Indicated for dilaon of stenosis located in the renal, iliac, femoral, popliteal and infrapopliteal arteries, and
for treang obstrucve lesions of nave or synthec arteriovenous dialysis stulae.
3. Contraindicaons
Inability to cross lesion with a guide wire.
INSTRUCTIONS FOR USE
BALLOON CATHETER FOR PERIPHERAL PREDILATION FOR 0.035” GUIDE WIRE.

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4. Warnings
-The device should only be used by experienced doctors in the percutaneous transluminal angioplasty
(PTA) technique.
-The percutaneous procedure must be carried out in hospitals equipped with emergency facilies to
conduct open heart surgery or hospitals with easy access to other hospitals where this type of opera-
on can be performed.
-The product is for single use. It must not be re-sterilised or re-used once the procedure has been com-
pleted. Re-using the product in another paent may lead to cross contaminaon, infecon or transmis-
sion of infecous diseases from one paent to another. Re-use of the product may cause alteraons
to it and aect its eecveness.
-The product is supplied sterile. Check the expiry date and do not use products which are past this date.
-Inspect the packaging before opening it. If there are any defects or the packaging is damaged, do not
use the product.
-Use asepc techniques when the product is taken out of the primary packaging.
-Select the balloon diameter according to the diameter of the artery to be treated. Do not insert a bal-
loon with a diameter larger than the artery to be treated.
-Do not dry with gauze.
-Do not expose the product to organic solvents or to contrast media not suitable for intravascular use.
-Do not use air or gaseous media to inate the balloon.
-Advance the product on the guide wire using uoroscopy. Do not allow the product to advance without
the guide wire inside it.
-Do not manipulate, advance or retract either the catheter or the wire guide while the balloon is in-
ated.
5. Precauons
-Administer suitable medical therapy to the paent: ancoagulants, vasodilators, etc., in accordance
with the procedure for inserng intravascular catheters.
-Before use, check the size and suitability of the catheter for its intended use.
-Proceed with extreme care so as not to damage the catheter while advancing it.
-The balloon must be inated with a mixture of saline soluon and contrast liquid (preferably 50/50,
though the proporon of contrast liquid can be reduced in large balloons).
-Do not exceed the rated burst pressure (RBP) as the balloon could burst.
-If any resistance is noted during advance, stop and determine its cause before connuing.
-If any resistance to withdrawing the catheter is noted, it is recommended that the balloon catheter, the
guide wire and introducer be removed as a single unit.
-Store in a cool, dry place away from direct sunlight.
-Aer use, this product may represent a biohazard. Handle and dispose it in accordance with accepted
medical pracces and pernent local, state or federal laws and regulaons.
6. Possible Adverse Eect / Complicaons
The possible adverse eects and/or complicaons which might arise before, during or aer the procedure
include the following:
•Death
•Ictus / embolism / thrombosis
•Haemodynamic deterioraon
•Acute elasc recoil
•Arrhythmia
INSTRUCTIONS FOR USE
BALLOON CATHETER FOR PERIPHERAL PREDILATION FOR 0.035” GUIDE WIRE.

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•Aneurysm or pseudo-aneurysm
•Infecons
•Total occlusion of the artery
•Reocclusion of the treated area: restenosis
•Spasm
•Perforaon or dissecon of the treated area
•Arteriovenous stula
•Local bleeding with haematoma at the access site
•Hypo/hypertension
•Allergic reacons to materials.
7. How to Use
7.1. Equipment Required
-Heparinized normal saline soluon.
-Contrast medium (use contrast media suitable for intravascular use).
-0.035” guide wire; do not use any other size of guide wire.
-Introducer with a haemostac valve of the size specied on the label. Do not use smaller sizes as these
might damage the catheter. If an introducer more than 25cm long or of the braided type is used, it may
be necessary to increase its size to avoid rubbing on the catheter.
-Three-way stopcock.
-Inaon device (manual pump with built-in manometer).
-Several standard 10-20cc syringes with saline soluon for washing the system.
7.2. Preparing the Catheter
-Remove the catheter from the protecve dispenser. Check that it is the right size. Remove the protec-
ve sheath from the balloon.
-Wash the product with a sterile isotonic saline soluon or similar on the outside and inside the channel
through which the guide wire passes, before inserng it into the paent.
-Connect a 10ml syringe containing sterile saline soluon to the port for the guide wire (straight part of
the connector) and irrigate the lumen unl the liquid comes out of the p.
-Purge the whole system of air:
•Aach a three-way stopcock to the contrast liquid connector port (the side part of the connector).
•Close the air passage through the balloon.
•Aach a 10-20ml syringe with a third part of saline soluon to the three-way stopcock.
•Open the passage in the three-way stopcock between the syringe and the catheter.
•With the syringe in a vercal posion, withdraw the plunger upwards allowing the air bubbles to
exit to the liquid.
•When bubbles stop coming in, close the three-way stopcock at the catheter end and remove the
syringe.
DANGER: If bubbles do not stop coming from the catheter into the syringe aer 3 minutes of nega-
ve pressure, this may be a clear indicaon that the balloon catheter has leaks, is broken or the
connecons between the syringe and the three-way key are not properly sealed. If bubbles connue
to be seen aer checking the connecons, do not use the device. Return it to the manufacturer or
distributor for inspecon.
7.3. Technique for Inseron / Treatment
-Posion the 0.035” guide wire across the lesion using PTA techniques, using uoroscopy to determine
its posion at all mes.
INSTRUCTIONS FOR USE
BALLOON CATHETER FOR PERIPHERAL PREDILATION FOR 0.035” GUIDE WIRE.