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ZOLL Cool Line CL-2295A/8700-0781-01 Instructions For Use Manual page 6

Intravascular heat exchange catheter

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Cool Line
Intravascular Heat Exchange Catheter (Custom Luer)
GuideWire Instructions for Use
Caution: Federal law (USA) restricts this device to sale and
use by or on the order of a physician.
Note: This information applies only to the use of guidewires in
the Seldinger technique of catheter placement in the
vasculature.
Warnings
The supplied guidewire is designed for single use only. Do not
resterilize or reuse. Do not reinsert, once removed from patient.
Should resistance occur during insertion or withdrawal, DO
NOT continue to move the guidewire. Determine the cause
under fluoroscopy and take action as needed.
Use extreme caution when moving a guidewire through a stent.
Use of a guidewire in stented vessels creates additional patient
risk.
Cautions
Avoid withdrawing the guidewire through metal needles; the
guidewire may shear.
Because of the delicate and fragile nature of guidewires, extra
care in handling must be taken. Avoid bending or kinking. Do
not use damaged guidewires.
Sufficient guidewire length must remain exposed to maintain
firm grip on the guidewire at all times.
Dispenser
Every guidewire is provided in a dispenser package. Remove
the guidewire anti-migration clip before dispensing the
guidewire. Remove the guidewire protective cap immediately
prior to guidewire use. Prepare the guidewire prior to insertion.
It is recommended that the dispenser be filled with heparinized
solutions (e.g. saline or dextrose) to bathe the guidewire during
insertion.
The preformed "J" guidewire will resume shape when removed
from the product dispenser.
1 = Guidewire protector cap
2 = Guidewire anti-migration clip
Inspection
Inspect the guidewire prior to use and discard if any deformities
are present in the guidewire. Guidewire placement should be
routinely monitored by x-ray or fluoroscopic procedure.
Instructions for Use
CL-2295A/8700-0781-01
Technique
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ZOLL
Puncture the vessel.
Insert the guidewire into the needle hub and gently
advance 5-10 cm of the guidewire into the punctured
vessel. Navigate the guidewire to the desired position.
Caution: Avoid rough or overly vigorous
manipulation of the guidewire to prevent damage to
the guide or the vessel.
Remove the needle from the guidewire.
Dilate the tissue and vessel with the dilator using a slight
rotary motion.
Remove the dilator. (The vessel dilator is intended for
vascular dilation only.)
Introduce the catheter by sliding it over the guidewire.
Remove the guidewire.

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