NC Euphora™
Rapid Exchange Balloon Dilatation Catheter
Cathéter de dilatation à ballonnet à échange rapide
Instructions for Use • Mode d’emploi
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Trademarks may be registered and are the property of their respective owners.
Les marques commerciales mentionnées peuvent être déposées et appartiennent à leurs propriétaires respectifs.
Explanation of symbols on package labeling / Explication des symboles des étiquettes sur l’emballage
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Refer to the device labeling to see which symbols apply to this product. / Se référer aux étiquettes sur le produit pour savoir
quels symboles s'appliquent à ce produit.
Inflation Pressure / Pression de gonflage
Balloon Length / Longueur du ballonnet
Balloon Diameter / Diamètre du ballonnet
Open Here / Ouvrir ici
Guide Catheter/Minimum Inner Diameter / Cathéter-guide/Diamètre interne minimum
Nominal Pressure / Pression nominale
Rated Burst Pressure / Pression théorique de rupture
Do Not Exceed Rated Burst Pressure / Ne pas excéder la pression théorique de rupture
Maximum Guidewire Diameter / Diamètre maximum du fil-guide
For Post Dilatation of Balloon Expandable Stents / Pour la post-dilatation de stents expansibles par ballonnet
Do Not Use if Package is Damaged / Ne pas utiliser si l'emballage est endommagé
Consult Instructions for Use at this Website / Consulter le mode d'emploi sur ce site Web
Do Not Reuse / Ne pas réutiliser
Use By / À utiliser jusqu'au
Lot Number / Numéro de lot
Catalog Number / Numéro de référence
Manufacturer / Fabricant
Sterilized Using Irradiation / Stérilisation par irradiation
For US Audiences Only / Ne s'applique qu'aux États-Unis
Manufactured In / Lieu de fabrication
Quantity / Quantité
Recycle / Recycler
Consult Instructions for Use / Consulter le mode d'emploi
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Rapid Exchange Balloon Dilatation Catheter / Cathéter de dilatation à ballonnet à échange rapide
Figure 1 / Figure 1
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NC Euphora™
Rapid Exchange Balloon Dilatation Catheter
1. Medtronic Balloon Catheter Description
The NC Euphora™ Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA)
Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific
pressure (see labelling). The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter
provides a lumen which enables the use of a guidewire to position the catheter.
Radiopaque balloon markers enable accurate placement. Shaft markers for brachial and femoral techniques are in place.
Contents
One balloon dilatation catheter
One flushing cannula
One refold tool
One looper device
One compliance chart
2. Indications
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The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft
stenosis for the purpose of improving myocardial perfusion.
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The balloon dilatation catheter is also indicated for postdeployment expansion of balloon expandable stents.
3. Contraindications
The catheter is contraindicated for use in:
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unprotected left main coronary artery
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coronary artery spasm in the absence of significant stenosis
4. Warnings
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For single patient, single procedure use only. Do NOT resterilize or reuse the device. Resterilization or reuse may
compromise device performance and increase the risk of inappropriate resterilization and cross contamination.
■
Do not use the catheter if its package has been opened or damaged.
■
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.
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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.
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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 as this can potentially
result in damage to the vessel wall. If resistance is met during manipulation, determine the cause of the resistance before
proceeding.
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Balloon pressure should not exceed the rated burst pressure indicated on the package label for each balloon. The rated
burst pressure is based on the results of in vitro testing. Use of a pressure monitoring device is recommended to prevent
overpressurization.
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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.
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Use only the recommended balloon inflation medium. To prevent the possibility of an air embolus, never use air or any
gaseous medium to inflate the balloon.
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Use the catheter prior to the Use By date specified on the package.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
5. Precautions
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Prior to angioplasty, examine the catheter to verify functionality and ensure that its size and shape are suitable for the
procedure for which it is to be used.
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If the device is kinked, it should not be used.
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The catheter system should be used only by physicians trained in the performance of percutaneous transluminal coronary
angioplasty.
■
Administer appropriate anticoagulation, antiplatelet, and vasodilator therapy to the patient.
Instructions for Use English 3
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