INVATEC SKIPPER DEEP Mode D'emploi page 3

Device Description
Invatec SKIPPEV DEEPis a steerable guidewire for PercutaneousTransluminal Angioplasty (PTA)
with a nominal diameter of 0.014" (0.36 mm) and with nominal lengths of 195 / 250 / 300 cm.
The guide wires are made of a single, full length, monolithic stainlesssteel core. A PTFE coating is
present in the proximal portion and a polymer iacket is mounted on the distal 7 cm. The jacket is
of Tecoflex'", a polymerwith a platinum micro-coilunderneathto providefluoroscopicvisibility.
Threedifferenttypesof tip flexibilityare availablerangingfrom Floppyto Stiff.The distalpart of the
guidewire is availablein straightconfiguration(handshapeable). P lease referto thesingleproduct
label for precise product specifications.
CAUTION: Extensivepre-shaping of the tip may lead to an increased friction inside the guide wire
lumen of the device to be tracked over the wire.
Indications
PTAGuide wires are intended to facilitate interventional devices introduction and positioning inside
theperipheralvessels duringPTAor other interventional p rocedures.
Contraindication
This Guide wire is not intended
Warnings
This device is designed and intended for single use only. DO NOT RESTERILIZE AND/OR
REUSE. I NVATECwill not be responsible for any direct, incidental or consequential damages
resultingfrom resterilizationor reuse.
Inspectthe device,prior to procedure,to verifyfunctionalityand lack of damagedparts.Do
not use the device if the outer or the inner package is damaged or opened.
Do not exposethe device to organic solvents,e.g. alcohol.
Whenthe guide wire is in the body, it should be manipulatedwhile under sufficientand/or
high qualityfluoroscopy.Do not attemptto advance the wire without paying careful visual
attention to the tip response.
Only physicians thoroughlytrainedand educatedin the performance of PTAshould usethis
device.Physicians s houldkeepthemselves i nformedand updatedon recentpublicationsabout
PTAtechniques.
Precautions
Use prior to n use before" date.
Appropriate drug therapy (anticoagulant,vasodilator,etc.) should be administeredto the
patientaccordingto standardprotocolsfor PTA.
Exercise care during handling in order to avoid possibledamage to the guide wire. Avoid
acute bending or kinking of the guide wire itself. Do not use a guide wire that has been
damaged. Do not attemptto straightena guide Wirethat has been kinkedor bent. Do not
advance a kinked guide wire into a balloon catheteror support catheterto reducethe
potential of wire breakage.
Keepat controlled room temperature, in a dry and dark place.
In orderto reducethe guidewire friction,it is recommended to wetthe SKIPPER T"DEEP guide
wireswitha sterilesalinesolutionimmediately prior to insertionin theintroducersheath.
for use in renal arteries and the cerebral
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vasculature.