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154-0280-2
Instructions for Use
Cordis NINJATM FX PTCA Dilatation Catheter
Mode d'emploi
Cathéter de dilatation PTCA Cordis NINJA FX
Gebrauchsanleitung
Cordis NINJA FX PTCA-Dilatationskatheter
Istruzioni per l'uso
Catetere dilatatore per PTCA NINJA FX Cordis
Instrucciones de uso
Catéter de dilatación NINJA FX PTCA de Cordis
Gebruiksaanwijzing
Cordis NINJA FX PTCA-dilatatiekatheter
Käyttöohjeet
Cordis NINJA FX PTCA -laajennuskatetri
Instruções de Utilização
Cateter de Dilatação para ACTP Cordis NINJA FX
Bruksanvisning
Cordis PTCA-dilatationskateter NINJA FX
√‰ËÁ›Â˜ ÃÚ‹Û˘
∫·ıÂÙ‹Ú·˜ ¢È·ÛÙÔÏ‹˜ PTCA NINJA FX Ù˘ Cordis
0086
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English ................................................................... Page ................................................................. 04
français .................................................................. page ................................................................. 07
deutsch .................................................................. Seite ................................................................. 10
italiano .................................................................... pagina .............................................................. 13
español .................................................................. página .............................................................. 16
Nederlands ............................................................. pagina .............................................................. 19
dansk ..................................................................... side .................................................................. 22
suomi ..................................................................... sivu ................................................................... 25
português ............................................................... página .............................................................. 28
svenska .................................................................. sid .................................................................... 31
∂ÏÏËÓÈο ................................................................ ™ÂÏ›‰· .............................................................. 34
japane .................................................................... japan ................................................................ 37
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STERILE. Sterilized with ethylene oxide gas. Nonpyrogenic. For one use only. Do not autoclave.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
I. Device Name
The device brand name is Cordis NINJA FX PTCA Dilatation
Catheter. The generic device name is PTCA balloon dilatation
catheter.
II. Description
Cordis PTCA catheters are designed for dilating stenotic
atherosclerotic lesions in coronary arteries. The catheter’s
dilating element is a balloon near the distal tip. The catheter
contains either one or two radiopaque marker bands. (See
package label for specific model.)
The catheter also has two (2) markers on the proximal shaft
which indicate, approximately, the exit of the balloon catheter tip
from the guiding catheter (brachial: 90 cm; femoral: 100 cm).
NINJA FX catheters are supplied with a standard “Y” connector.
The balloon is inflated by injecting diluted contrast medium
solution through the distal (at 45o angle) Luer port of the integral
connector.
The catheter requires that an accessory hemostasis valve be
connected to the proximal (straight) Luer port. The maximum
guidewire diameter that may be used is printed on the package
label.
Note: The rated burst pressure is printed on the
package label. In vitro testing has shown that with 95%
confidence, 99.9% of the balloons will not burst at or
below the rated burst pressure. Balloons should not be
inflated in excess of the rated burst pressure.
The Compliance Table shows how the balloon
diameters increase as pressure increases. The table
also includes the pressure at which the balloons inflate
to their nominal diameters.
III. Indications
The Cordis PTCA catheters are indicated for balloon dilatation of
the stenotic portion of a coronary artery or bypass graft stenosis
for the purpose of improving myocardial perfusion.
The NINJA FX is indicated for measurement using the dual
balloon marker bands. Nominal values between the inner and
outer edges of the marker bands are:
• PTCA in patients who are not acceptable candidates for
coronary artery bypass graft surgery requires careful
consideration, including possible hemodynamic support
during PTCA, as treatment of this patient population carries
special risk.
• When the catheter is exposed to the vascular system, it
should be manipulated while under high-quality fluoroscopic
observation. Do not advance or retract the catheter unless the
balloon is fully deflated under vacuum. If resistance is met
during manipulation, determine the cause of the resistance
before proceeding.
• Balloon pressure should not exceed the rated burst pressure.
The rated burst pressure is based on the results of in-vitro
testing. At least 99.9% of the balloons (with 95% confidence)
will not burst at or below their rated burst pressure. Use of a
pressure monitoring device is recommended to prevent over
pressurization.
• PTCA should only be performed at hospitals where
emergency coronary artery bypass graft surgery can be
quickly performed in the event of a potentially injurious or life-
threatening complication.
• Use only the recommended balloon inflation medium. Never
use air or any gaseous medium to inflate the balloon.
• Use the catheter prior to the “Use By” date specified on the
package.
• The Cordis NINJA FX PTCA dilatation catheters are not
intended for stent expansion.
VI. Precautions
• Prior to angioplasty, the catheter should be examined to verify
functionality and ensure that its size and shape are suitable
for the specific procedure for which it is to be used.
• The catheter system should be used only by physicians
trained in the performance of percutaneous transluminal
coronary angioplasty.
• Appropriate anticoagulant/antiplatelet and coronary
vasodilator therapy should be used during this procedure.
VII. Adverse Effects
Possible adverse effects include, but are not limited to, the
following:
• death
• acute myocardial infarction
• total occlusion of the coronary artery or bypass graft
• coronary vessel dissection, perforation, rupture or injury
• restenosis of the dilated vessel
Balloon
Length (mm)
Inner to Inner Outer to Outer
Distance (mm) Distance (mm)
• hemorrhage or hematoma
• unstable angina
10
15
18
20
25
30
40
IV. Contraindications
7.5
12.0
15.0
17.0
21.5
25.5
35.5
9.5
14.0
17.0
19.0
23.5
27.5
37.5
• arrhythmias, including ventricular fibrillation
• drug reactions, allergic reaction to contrast medium
• hypo/hypertension
• infection
• coronary artery spasm
• arteriovenous fistula
• embolism
VIII. Contents
• Unprotected left main coronary artery.
• Coronary artery spasm in the absence of a significant
stenosis.
V. Warnings
• This device is intended for one time use only. Do NOT
resterilize and/or reuse it, as this can potentially result in
compromised device performance and increased risk of
inappropriate resterilization and cross contamination.
• To reduce the potential for vessel damage, the inflated
diameter of the balloon should approximate the diameter of
the vessel just proximal and distal to the stenosis.
* Ethiodol is a trademark of Guerbet S.A.
4
• One PTCA balloon dilatation catheter
• One distal pin
• One protective sheath
IX. Instructions for Use
Note: Do not use with Ethiodol* or Lipiodol contrast medium, or
other such contrast medium, which incorporates the components
of these agents.
Note: Do not expose the catheter to organic solvents
(e.g., alcohol).
Note: Do not use if the inner package is open or damaged.
Note: Do not autoclave. Exposure to temperatures above 54oC
(130oF) may damage the catheter.
Note: Store in a cool, dark, dry place.
Pressure
atm
Compliance Table: Balloon Diameter vs. Inflation Pressure
These data are based on in-vitro testing of DURALYNTM balloons at 37oC.
In-vitro balloon diameters will be within 6% of the specified diameter between the nominal pressure and the rated burst pressure.
Bolded text represents pressures above the rated burst pressure.
Preparation and Inspection Procedure
Note: Some of the NINJA FX catheters are coated with a
hydrophilic coating which is activated when wet (refer to
product label).
1. Carefully remove the catheter from the package.
2. Remove the forming tube from the distal end of the catheter.
3. Attach a stopcock to the catheter’s distal (at 450 angle) Luer
port (inflation lumen).
4. Submerge the balloon in sterile normal saline solution to
activate the hydrophilic coating.
Note: If the balloon surface of the NINJA FX catheter
becomes dry, wetting with normal saline will reactivate the
coating.
5. Attach a 20-cc syringe to the stopcock and apply negative
pressure, pulling the syringe back as far back as possible
without dislodging it from the syringe barrel.
6. Hold the syringe and the proximal end of the dilatation
catheter above the distal end of the catheter, and hold the
balloon vertically with the balloon tip pointing down.
7. Close the stopcock to the inflation port.
8. Remove the syringe and purge the air.
9. Reattach the 20-cc syringe to the stopcock, open the
stopcock and again apply negative pressure, pulling the
syringe plunger as far back as possible without dislodging it
from the syringe barrel.
10. Close the stopcock to the inflation port and remove the
syringe.
Note: To ensure air contained in the balloon and inflation
lumen is removed, it is recommended that negative
pressure be applied twice. Open the stopcock only when the
syringe is in place with negative pressure applied.
11. Fill the 20-cc syringe with 3-cc of a 50% solution of
Renografin 60 contrast medium (or similar contrast medium)
in sterile saline or water and reattach it to the stopcock.
Caution: Nonionic contrast medium has different viscosity
and precipitation levels than does the ionic type, and it may
prolong inflation/deflation times.
12. While applying positive pressure, slowly open the stopcock
and allow the contrast solution to flow slowly into the
inflation lumen and balloon.
Note: Do not exceed rated burst pressure.
13. All air should be expelled from the balloon and inflation
lumen. If air bubbles are seen in the system, point the
balloon tip down, lightly tap the balloon, apply negative
pressure with the syringe and repeat steps 6-12.
14. Visually inspect the balloon and inflation lumen to ensure all
air has been removed.
15. Apply negative pressure and close the stopcock or attach an
inflation device that may be left at negative pressure until
the balloon is ready to be used.
Assembly and Insertion Procedure
1. Attach a prepared angioplasty inflation system to the PTCA
catheter’s distal (at 45o angle) Luer port.
5
2. Attach an accessory guidewire hemostasis valve of choice
to the proximal (straight) Luer port. Insert the distal end of
the guidewire into the hemostasis valve and proximal
(straight) Luer port.
Note: If the usable length of the catheter (see package
label) is longer than 150 cm, selection of a 300 cm
guidewire, or a guidewire with an extension is required.
3. Advance the guidewire through the catheter. Seal the
hemostasis valve around the guidewire.
4. Attach a second hemostasis valve to the Luer port of an
appropriate guiding catheter. Verify compatibility of the
hemostasis valve and the largest catheter shaft diameter
(see package label).
5. After the guiding catheter has been positioned, flush the
guidewire lumen with sterile saline or a similar isotonic
solution, and insert the PTCA catheter through the
hemostasis valve on the guiding catheter.
6. Advance the PTCA catheter to the distal end of the guiding
catheter.
Note: The exit marker(s) may be used in locating this
position.
Caution: Fully deflate the balloon by maintaining negative
pressure with the inflation system whenever the PTCA
catheter is advanced or withdrawn. Do not advance or
withdraw the PTCA catheter within the coronary vasculature
unless the catheter is preceded by a guidewire.
Caution: If a Tuohy-Borst type adjustable hemostasis valve
is used, avoid overtightening since this may restrict the flow
of contrast medium in and out of the balloon, thereby
slowing inflation/deflation.
7. Using fluoroscopy, proceed with accepted PTCA techniques
to advance the guidewire to and across the lesion.
8. Continue under fluoroscopy and use the radiopaque marker
band(s) to position the usable (dilating) section of the
balloon within the stenosis.
9. Continue the procedure using accepted coronary
angioplasty technique to dilate the stenosis.
Note: Do not exceed the rated burst pressure printed on the
package label.
Note: Balloon inflation should be performed with the
guidewire extended beyond the catheter tip. It is strongly
recommended that the guidewire, the balloon catheter, or
both remain across the lesion until the procedure is
complete and the dilatation system is to be removed from
the vessel.
Withdrawal and Disassembly Procedure
1. Withdraw the deflated PTCA catheter and guidewire into the
guiding catheter.
2. Using a technique of choice, remove the PTCA catheter,
guidewire and guiding catheter from the vasculature.
3. Discard the PTCA catheter, guidewire, and guiding catheter.
X. References
The physician should consult recent literature on current medical
practice on balloon dilatation, such as that published by ACC/
AHA.
Date of modified labeling: March 2000.
6
DISCLAIMER OF WARRANTY AND LIMITATION OF
REMEDY
THERE IS NO EXPRESS OR IMPLIED WARRANTY,
INCLUDING WITHOUT LIMITATION ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, ON THE CORDIS PRODUCT(S)
DESCRIBED IN THIS PUBLICATION. UNDER NO
CIRCUMSTANCES SHALL CORDIS BE LIABLE FOR ANY
DIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES
OTHER THAN AS EXPRESSLY PROVIDED BY SPECIFIC
LAW. NO PERSON HAS THE AUTHORITY TO BIND
CORDIS TO ANY REPRESENTATION OR WARRANTY
EXCEPT AS SPECIFICALLY SET FORTH HEREIN.
Descriptions or specifications in Cordis printed matter,
including this publication, are meant solely to generally
describe the product at the time of manufacture and do
not constitute any express warranties.
Cordis Corporation will not be responsible for any direct,
incidental, or consequential damages resulting from
reuse of the product.
Cordis Sales / Marketing Offices:
Cordis Operations:
Austria:
Cordis Ges. M.B.H.
Baslergasse 17
A-1230 Wien
Telephone 0043-1-661120
Belgium:
Johnson & Johnson Medical N.V./S.A.
Leuvensesteenweg 510 bus 42
B-1930 Zaventem
Telephone (32-2) 725 81 29
Canada:
Johnson & Johnson Medical Products
1421 Lansdowne Street West
Peterborough, Ontario
Canada K9J 7B9
Telephone 705-741-6100
European HQ:
Cordis International SA
Waterloo Office Park
Building H
Drève Richelle 161
B-1410 Waterloo
Belgium
Telephone 02/352 14 11
Hong Kong:
Cordis Regional Office
Rm 1311-12, Grand Century Place
Tower 1, 193 Prince Edward Road W.
Mongkok, Kowloon
Tel: (852) 2738 2888
Italy:
Cordis Italia S.p.A.
Piazza Don E. Mapelli n. 1
20099 Sesto San Giovanni MI
Telephone 39-2-242041
Japan:
Cordis
Johnson & Johnson K.K.
East 21 Tower 10th Floor
6-3-2 Toyo, Koto-ku
Tokyo 135
Telephone 03-5632-7200
The Netherlands:
Cordis Europa N.V.
Postbus 38
NL-9300 AA Roden
Telephone 050-5022222
Portugal:
Johnson & Johnson Produtos
Profissionais
Estr. Consiglieri Pedroso N. 69-A
Queluz de Baixo
2745-555 Barcarena
Telephone 351 1 436 87 70/1/2/3/4
Spain:
Johnson & Johnson S.A.
Paseo de las doce Estrellas, 5-7
Campo de las Naciones
28042 - Madrid
Tel: (91) 722 8000
Sweden:
Johnson & Johnson AB
Staffans väg 2
SE-191 84 SOLLENTUNA
Tel: +46-8-626 22 00
Switzerland:
Cordis AG
Gaswerkstrasse 48
CH-4900 Langenthal
Telephone 063-22-88-55
United Kingdom:
Cordis U.K. Ltd.
Unit 9, The Gate Centre
Syon Gate Way
Brentford, Middlesex TW8 9DD
Telephone 0181-568-1991
Translation - Croatian CORDIS® 0086
Johnson & Johnson
154-0280-2
Upute za upotrebu
Cordis NINJATM FX PTCA dilatacijski kateter
Engleski………………………………………Stranica…………………………………………4
STERILNO: Sterilizirano plinom etilen oksida. Nepirogeno. Rendgenski dobro vidljivo. Samo za jednokratnu upotrebu. Nemojte sterilizirati u autoklavu.
Oprez: Savezni zakon (SADa) ograničava prodaju ovog proizvoda prema uputi ili nalogu liječnika.
I. Naziv proizvoda
Zaštićeno ime proizvoda je NINJA FX PTCA Cordis dilatacijski kateter, generički naziv proizvoda je PTCA balon kateter za dilataciju.
II. Opis proizvoda
Cordis PTCA kateteri su dizajnirani za dilataciju sklerotičnih aterosklerotičnih lezija u koronarnim arterijama. Dilatacijski element katetera je balon koji se nalazi blizu distalnog vrha. Na kateteru se nalaze jedan ili dva rendgenski dobro vidljiva pojasa markera (Vidi etiketu na pakiranju za specifični model).
Kateter ima također dva (2) markera na proksimalnom dijelu koji približno pokazuju izlaz vrha balon katetera iz vodiljnog katetera (brahijalni: 90cm; femoralni:100cm).
NINJA FX kateteri isporučuju se sa standardnim "Y" konektorom. Balon se napuhuje ubrizgavanjem otopine kontrastnog sredstva kroz distalni Luer otvor (pod kutem od 45°) konektora.
Potrebno je priključivanje pomoćne hemostatske valvule na proksimalni (ravni) Luer otvor.
Maksimalni promjer žice vodilje koja se može koristiti ispisana je na etiketi pakiranja.
Napomena: Maksimalni dopušteni pritisak koji se može primijeniti otisnut je na etiketi pakiranja. In vitro testiranje pokazalo je s pouzdanošću od 95%, da 99,9% balona neće puknuti pri ili ispod maksimalno dopuštenog pritiska. Baloni se ne smiju napuhati preko maksimalno dopuštenog pritiska.
Tablica podudarnosti pokazuje kako se promjeri balona povećavaju s povećavanjem pritiska. Tablica sadrži i pritisak pri kojem se baloni napuhnu do svog nominalnog promjera.
III. Indikacije
Cordisovi PTCA kateteri namijenjeni su za dilataciju stenoznih dijelova koronarne arterije ili stenoze premosnog grafta s ciljem poboljšanja miokardijalne perfuzije.
NINJA FX je namijenjen za mjerenje pomoću upotrebe dvostrukih pojasa markera balona. Nominalne vrijednosti između unutarnjih i vanjskih krajeva pojasa markera su:
Dužina balona (mm) Razmak unutrašnjih dijelova (mm) Razmak vanjskih dijelova (mm)
10 7.5 9.5
15 12.0 14.0
18 15.0 17.0
20 17.0 19.0
25 21.5 23.5
30 25.5 27.5
40 35.5 37.5
IV. Kontraindikacije
· Nezaštićena lijeva glavna koronarna arterija.
· Spazam koronarne arterije uz izostanak značajne stenoze
V. Upozorenja
– Ovaj proizvod je namijenjen samo za jednokratnu upotrebu. NE ponovo sterilizirati i/ili ponovo koristiti jer to, potencijalno može rezultirati nepravilnim radom proizvoda i povećanim rizikom od neodgovarajuće ponovne sterilizacije i međusobne kontaminacije.
– Da bi se smanjila mogućnost oštećenja krvne žile, promjer napuhanog balona treba biti približan promjeru krvne žile proksimalno i distalno u odnosu na stenozu.
– PTCA u pacijenata koji nisu prikladni kandidati za operaciju koronarne arterije premosničkim graftom zahtjeva pažljivo razmatranje, uključujući moguću hemodinamičku potporu tijekom PTCA, jer liječenje ove populacije pacijenata nosi određene rizike.
– Kada se kateter postavlja u vaskularni sustav, njime se treba rukovati pod visoko-kvalitetnim fluoroskopskim promatranjem. Nemojte pomicati kateter prema naprijed ili izvlačiti ga ukoliko se balon u cijelosti ne ispuše pod vakuumom. Ako postoji otpor prilikom rukovanja, odredite uzrok otpora prije nego nastavite s postupkom.
– Pritisak balona ne smije prelaziti maksimalni dopušteni pritisak. Maksimalni dopušteni pritisak baziran je na rezultatu in-vitro testiranja. Bar 99,9% balona (uz pouzdanost od 95%) neće puknuti pri ili ispod maksimalno dopuštenog pritiska. Preporučuje se upotreba uređaja za praćenje pritiska kako bi se spriječila pojava prevelikog pritiska.
– PTCA može biti samo izvršen u bolnicama gdje se može brzo izvršiti hitna operacija koronarne arterije premosničkim graftom kod slučajeva komplikacija potencijalno opasnih po život.
– Koristite samo preporučeno sredstvo za napuhavanje balona. Nemojte nikada koristiti zrak ili bilo koje plinovito sredstvo kako biste napuhali balon.
– Upotrijebite kateter prije datuma isteka roka za upotrebu, specificiranog na etiketi pakiranja.
– NINJA FX PTCA Cordisovi dilatacijski kateteri nisu namijenjeni za dilataciju stenta.
VI. Mjere predostrožnosti
– Prije angioplastike, kateter se treba pregledati kako bi se provjerila funkcionalnost i kako bi se osigurala pogodnost njegove veličine i oblika za specifični postupak koji se treba koristiti.
– Sustav katetera trebaju koristiti samo liječnici koji su educirani za izvođenje arteriografije i koji su prošli odgovarajuću obuku iz perkutane transluminalne koronarne angioplastike.
– Tijekom ovog postupka potrebno je koristiti terapiju prikladnim antikoagulansima/tvarima protiv stvaranja tromba te koronarnim vazodilatatorima.
VII. Štetni učinci
Mogući štetni učinci uključuju, ali nisu ograničeni na:
– smrt
– akutni miokardijalni infarkt
– potpunu okluziju koronarne arterije ili premosničkog grafta
– napuknuće koronarne žile, perforacija, ruptura ili traumatska ozljeda
– ponovna stenoza dilatirane krvne žile
– krvarenje ili hematom
– bolnost u prsima
– aritmije, uključujući ventrikularnu fibrilaciju
– preosjetljivost na lijekove ili kontrastno sredstvo
– hipo/hipertenzija
– infekcija
– spazam koronarne arterije
– arteriovenozna fistula
– embolija
VIII. Sadržaj
– jedan PTCA dilatacijski balon kateter
– jedan distalni pin
– jedan zaštitni ovoj
IX. Upute za upotrebu
Napomena: Ne koristiti s kontrastnim sredstvom Ethiodol* ili Lipiodol ili s bilo kojim drugim kontrastnim sredstvom koji sadrži komponente tih sredstava.
Napomena: Ne izlagati kateter organskim otapalima (npr. alkohol).
Napomena: Nemojte ga koristiti ako je unutrašnje pakiranje otvoreno ili oštećeno.
Napomena: Nemojte ga sterilizirati u autoklavu. Izlaganje temperaturama iznad 54°C (130°F) može oštetiti kateter.
Napomena: Pohranite ga na hladnom, tamnom, suhom mjestu.
* Ethiodol je trgovački znak za Guerbet S.A.
Tabela podudarnosti. Promjer balona u odnosu na pritisak napuhavanja
Pritisak
Ti su podaci zasnovani na in-vitro testiranju balona DURALYN™ pri 37°C. Stvarni promjeri balona in-vivo bit će unutar 6% od specificiranog promjera između nominalnog pritiska i maksimalno dopuštenog pritiska. Podebljan tekst predstavlja pritiske iznad maksimalno dopuštenog pritiska.
Postupak pripremanja i provjere
Napomena: Neki od NINJA FX katetera imaju hidrofilnu ovojnicu koja se aktivira pri dodiru s vlažnim površinama ( vidi etiketu proizvoda).
1. Pažljivo izvadite kateter iz pakiranja.
2. Uklonite formirajuću cijev sa distalnog kraja katetera.
3. Pričvrstite (pod kutem od 45°) zaustavni ventil na distalni Luer otvor katetera (lumen za napuhavanje).
4. Uronite balon u sterilnu uobičajenu fiziološku otopinu kako bi aktivirali hidrofilni ovoj.
Napomena: ako površina balona NINJA FX katetera postane suha, vlaženje s fiziološkom otopinom će ponovno aktivirati hidrofilnu ovojnicu.
5. Pričvrstite špricu od 20 ccm na zaustavni ventil, otvorite zaustavni ventil i napravite negativni pritisak tako da povučete klip šprice što je moguće više prema natrag, a da vam pritom ne ispadne van iz šprice.
6. Držite špricu i proksimalni kraj dilatacijskog katetera iznad distalnog kraja katetera, te držite balon okomito s vrhom balona okrenutim prema dolje.
7. Zatvorite zaustavni ventil na otvoru za napuhavanje.
8. Izvadite špricu i istisnite zrak.
9. Ponovo pričvrstite špricu od 20 ccm na zaustavni ventil, otvorite zaustavni ventil i napravite negativni pritisak tako da povučete klip šprice što je moguće više prema natrag, a da pritom ne ispadne van iz šprice.
10. Zatvorite zaustavni ventil na otvoru za napuhavanje i izvadite špricu.
Napomena: Da biste osigurali uklanjanje zraka sadržanog u balonu i uklanjanje lumena za napuhavanje, preporučuje se dva puta inducirati negativni pritisak. Otvorite zaustavni ventil samo kada je šprica na mjestu, a negativni pritisak se održava.
11. Napunite špricu od 20 ccm s 3 ccm 50% otopine kontrastnog sredstva (ili sličnim kontrastnim sredstvom) u sterilnoj fiziološkoj otopini ili vodi, te je ponovo spojite na zaustavni ventil.
Oprez: Neionsko kontrastno sredstvo ima različite razine viskoznosti i taloženja nego ionski tip, što može produžiti vrijeme napuhavanja/ispuhavanja.
12. Primjenjujući pozitivni pritisak, polako otvorite zaustavni ventil i pustite da kontrastna otopina polako teče u lumen za napuhavanje i balon.
Napomena: Nemojte prelaziti maksimalni dopušteni pritisak ispisan na etiketi na pakiranju.
13. Iz balona i lumena za napuhavanje treba se istisnuti sav zrak. Ako se u sustavu vide mjehurići zraka, usmjerite vrh balona prema dolje, lagano lupnite balon, inducirajte negativni pritisak pomoću šprice i ponovite korake 6-12.
14. Pregledajte balon i lumen za napuhavanje kako biste se uvjerili da je zrak uklonjen.
15. Inducirajte negativni pritisak i zatvorite zaustavni ventil ili pričvrstite uređaj za napuhavanje koja se može ostaviti pod negativnim pritiskom dok balon ne bude spreman za upotrebu.
Spajanje i uvođenje
1. Pričvrstite pripremljeni inflacijski sistem za angioplastiku na PTCA kateter na distalni Luer otvor (pod kutem od 45°).
2. Pričvrstite pripadajuću hemostatsku valvulu žice vodilje po izboru na proksimalni (ravni) Luer otvor. Umetnite distalni kraj žice vodilje u hemostatsku valvulu i proksimalni (ravni) Luer otvor.
Napomena: Ako je sveukupna dužina katetera (vidi etiketu na pakiranju) duža od 150 cm, potreban je odabir žice vodilje od 300 cm ili žice vodilje s produženjem.
3. Pomaknite žicu vodilju prema naprijed kroz kateter. Pričvrstite hemostatsku valvulu oko žice vodilje.
4. Pričvrstite drugu hemostatsku valvulu na Luer otvor odgovarajućeg vodećeg katetera. Provjerite kompatibilnost hemostatske valvule i najvećeg promjera tijela katetera (vidjeti etiketu na pakiranju).
5. Nakon što namjestite vodiljni kateter, isperite lumen žice vodilje sterilnom fiziološkom otopinom ili sličnom izotoničkom otopinom, te umetnite PTCA kateter kroz hemostatsku valvulu na vodiljnom kateteru.
6. Pomaknite PTCA kateter do distalnog kraja vodiljnog katetera.
Napomena: izlazni marker(i) mogu se koristiti pri lociranju ovog položaja.
Oprez: Ispuhnite balon induciranjem negativnog pritiska svaki put kada se PTCA kateter pomiče prema naprijed ili izvlači. Nemojte pomicati prema naprijed ili izvlačiti PTCA kateter unutar krvne žile ukoliko kateteru ne prethodi žica vodilja.
Oprez: Ako se koristi podesivi tip hemostatske valvule Tuohy-Borst, izbjegavajte je previše zategnuti budući da to može ograničiti protok kontrastnog sredstva u i iz balona, čime se usporava napuhavanje/ispuhavanje.
7. Korištenjem fluoroskopije, proslijedite s PTCA tehnikama da biste pomaknuli žicu vodilju do i preko lezije.
8. Nastavite pod fluoroskopijom, te upotrijebite markerski pojas (pojaseve) kako biste namjestili upotrebljivi (dilatirajući) dio balona unutar stenoze.
9. Nastavite postupak koristeći prihvaćenu tehniku koronarne angioplastike za dilataciju stenoze.
Oprez: Nemojte prekoračiti maksimalni dopušteni pritisak naznačen na etiketi na pakiranju.
Napomena: Napuhavanje balona treba se izvršiti tako da se žica vodilja istegne dalje od vrha katetera. Izričito se preporučuje da žica vodilja, balon kateter, ili oboje ostanu preko lezije sve dok se postupak ne dovrši i dok se sustav dilatacije ne izvadi iz krvne žile.
Postupak izvlačenja i rastavljanja
1. Uvucite ispuhnuti PTCA kateter i žicu vodilju u vodiljni kateter.
2. Koristeći odabranu tehniku, uklonite PTCA kateter, žicu vodilju i vodiljni kateter iz krvne žile.
3. Neškodljivo uklonite PTCA kateter, žicu vodilju i vodiljni kateter.
X. Reference
Liječnik treba konzultirati najnoviju literaturu o sadašnjoj medicinskoj praksi za dilataciju balonom, kao što je literatura objavljena od ACC/AHA.
Datum izmjene etikete: ožujak 2000.
Odricanje od jamstva i ograničenje pravnog lijeka
Nema nikakvog izričitog ili impliciranog jamstva, uključujući, bez ograničenja, bilo kakvo implicirano jamstvo za mogućnost prodaje ili podobnost za pojedinu svrhu, za proizvod(e) Cordis opisan(e) u ovoj publikaciji. Cordis ni u kojem slučaju neće biti odgovoran za bilo kakve direktne, slučajne ili posljedične štete osim ako je izričito navedeno u specifičnom zakonu. Nijedna osoba nema ovlaštenje obvezati Cordis na bilo kakav navod ili jamstvo osim ako je ovdje izričito navedeno.
Opisi ili specifikacije na štampanom materijalu Cordisa, uključujući ovu specifikaciju, namijenjeni su isključivo za općenito opisivanje proizvoda u vrijeme proizvodnje, te ne predstavljaju nikakva izričita jamstva.
Cordis Corporation ni u kojem slučaju neće biti odgovorno za bilo kakve direktne, slučajne ili posljedične štete proizišle iz ponovne upotrebe ovog proizvoda.
Cordisovi uredi za prodaju/marketing:
Austrija:
Johnson & Johnson Medical Products GmbH
Cordis Division, Gunoldstrasse 16, A-1190 Beč
Telefon 01-360 25-0
Belgija:
Cordis, a Johnson & Johnson Company,
Johnson & Johnson Medical N.V./S.A.
Eikelenbergstraat 20, B-1700 Dilbeek
Telefon 02-481 74 00
Kanada:
Johnson & Johnson Medical Products
200 Whitehall Drive
Markham, Ontario, Kanada L3R 0T5
Telefon 905-946-1611
Europska centrala:
Cordis, a Johnson & Johnson Company,
Johnson & Johnson Medical N.V./S.A.
Waterloo Office Park, Building H
Drève Richelle 161, B-1410 Waterloo,
Belgija
Telefon 02-352 14 11
Francuska:
Cordis S.A.S.
1 Rue Camille Desmoulins, TSA 71001
F-92787 Issy les Moulineaux Cedex 9
Telefon 01 55 00 33 00
Hong Kong:
Johnson & Johnson Hong Kong, Ltd., Medicinski odjel
Rm 1816-1819, 18/F Grand Century Place
Tower 1, 193 Prince Edward Road West
Mongkok, Kowloon
Telefon 2738 2818
Italija:
Cordis Italia S.p.A.
Via Chiese, 74, I-20126 Milano
Telefon 02-64410.1
Japan:
Cordis Japan
Johnson & Johnson K.K.
East 21 Tower 10.kat
6-3-2 Toyo, Koto-ku, Tokyo 135-0016
Telefon 03-5632-7200
Nizozemska:
Johnson & Johnson Medical BV
Postbus 188, NL-3800 AB Amersfoort
Telefon 033-450 0729
Portugal:
Johnson & Johnson Produtos Profissionais
Estr. Consiglieri Pedroso N° 69-A
Queluz de Baixo, PT-2745-555 Barcarena
Telefon 800 200 246
Španjolska:
Johnson & Johnson S.A.
Paseo de las doce Estrellas, 5-7
Campo de las Naciones, E-28042 Madrid
Telefon 91 722 8000
Švedska:
Johnson & Johnson AB
Staffans väg 2, SE-191 84 Sollentuna
Telefon 08-626 22 00
Švicarska:
Johnson & Johnson AG, Cordis Division
Rotzenbühlstrasse 55,
CH-8957 Spreitenbach
Telefon 056-417 3207
Velika Britanija:
Cordis, a Johnson & Johnson Company
Johnson & Johnson Medical Ltd.
Coronation Road, South Ascot
Berkshire SL5 9EY
Telefon 01344 871000
Education and qualifications: SSS (grammar school), VSS (Doctor of veterinary medicine)
1994- I`m registered as a regular student at the Veterinary University in Zagreb
1995-1996- worked as a research assistant to prof. dr. sc. Đuro Huber and doc.dr.sc. Kusak at the Biology department of the Veterinary University in Zagreb and also researched bears in Gorski kotar.
1998- 1 month of education at the Surgery clinic University in Wien, Austria (Chirurgische Klinik und Augenklinik der Veterinarmedizinischen Universitat in Wien).
(from August till December 1999.)- I was in Canada, worked at the farm of hunting dogs (beagles) and beef cows, and also assisted at the Veterinary clinic of D.V.M. Luc Versavel, Stonewall, Manitoba (large and small animals).
- in the academic year 1999/2000- I got a Dean reward for researching project about the influence of antibiotic Gentamicin on animal bacterial sorts.
-1995-2000- I worked as a volunteer at the Veterinary clinic Velika Gorica (large and small animals).
- at September, 2003.- I helped in communication among Great Britain commission and professors of Veterinary University in Zagreb, Croatia.
-2004.- I worked in a wholesale (livestock food, dog and cat food, vitamins, mineral salts…).
-In October 2004- I finished Veterinary University with a very good success.
Additional preferences:
-Excellent usage of english language (written and spoken)
- Knowledge of MsOffice tools- Word, Excel, Outlook, Internet, PowerPoint, CorelDraw, DesignPro, Adobe Photo Shop)
- creating of advertising pages, brochures…
-typing
- general knowledge of german and italian language
-driver licence (B cat.)
-sale training course
- 5 years of working experience as a translator of SAP (Software Application Package) from english to croatian language, in an international environment, with usage of SLS (SAP`s Language Services) handbook, QETT (Quality Evaluation Tool for Translation), SAPterm (online terminology data base), comparison of translated phrases with phrasis in other languages (german, italian, french, dutch, danish, spanish…) One Voice Style Guide and One Voice Positioning Handbook rules, Solution Maps on SAPNet.
- 10 years of experience as a freelance translator (specialized in medical translations)
- I have 12 m. of working experience as a Medical Sales and Marketing Representative of medical products in hospitals abroad Croatia.
- 2 years of experience as Sales support (managing all office work, regulatory affairs regarding registration of medical products, re-registration of medical products, correspondence to Agency of drugs and medical products, registration documents preparation, registration of products in Croatia and Serbia, communication with suppliers- asking for CE and ISO product certificates (notifying body is TUV), translating, inocorespondence...) at the international medicine oriented company.
- year 2008.- I founded my own company „Interlingo“ specialized in medical translations.
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