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ENGLISH
DESCRIPTION AND INDICATIONS FOR USE
The PINNACLE INTRODUCER consists of an introducer (a sheath
and a dilator), a mini guidewire, a guide inserter, and may
contain an introducer needle.
The Pinnacle Introducer is used to facilitate placing a catheter
through the skin into a vein or artery. The mini guidewire is an
accessory device which is used for placement of the sheath into
the vein or artery. The introducer needle is an accessory device
which is used in facilitating entry through the skin into a vein or
artery to provide a conduit for the mini guidewire.
COMPONENT DESCRIPTION
Refer to product labeling for appropriate system components. All
components that enter blood vessels are radiopaque.
Sheath
Incorporates a 1-way valve and a 3-way stopcock connected by
a side tube. The sheath can be used with a catheter of the same
Fr. size or up to two Fr. sizes smaller without blood leakage at
the 1-way valve. This highly fl exible sheath is designed to resist
kinking.
Dilator
The precise fi t of the dilator in the sheath allows for simultaneous
motion of both dilator and sheath.
Spring Coil Mini Guidewire or Nitinol Mandrel Guidewire
A 45 cm stainless steel guidewire or 43 cm Nitinol guidewire with
0.21 inch, 0.35 inch or 0.38 inch outside diameter is included
depending on the catalog number of the system.
Guide Inserter
Before inserting the mini guide wire, the guide inserter can be
set at the entry of the needle hub for easy insertion.
Needle
The introducer needle is an accessory device which is used in
facilitating the entry through the skin into a vein or artery to
provide a conduit for the mini guidewire. The needle has a
tapered distal end to provide 21Ga access to vessel. Needle may
be included depending on catalog number of the system.
The contents of this package may diff er from that
shown in the instructions for use. Please consult
available catalog information for proper contents.
Dilator
Mini Guidewire
Needle
Sheath
Guide Inserter
PRECAUTIONS
•
When using metal needle cannula, do not withdraw
the guidewire back into the cannula, as shearing of the
guidewire may result.
•
This kit must be used by a trained physician.
•
This kit is for single use only. Do not resterilize or reuse.
Instructions for Use
PM-01979
