Merit Medical Fountain 4 French Infusion System - Manual (Page 3)

I NTENDED U SE OF P RODUCT
A. I
NDICATIONS
The Fountain Infusion System is intended to
administer infusions of various therapeutic
solutions into the peripheral vasculature of a
patient.
B. C
ONTRAINDICATIONS
The Fountain Infusion System is contraindi-
cated for use in the coronary vasculature.
The Fountain Infusion System is contraindi-
cated for use during magnetic resonance
imaging.
C. C
AUTIONS
Do not use the Fountain Infusion System
with a power injector. Damage to the
catheter or hemostasis valve may occur.
Do not infuse solution through the
Fountain Infusion System without the Merit
Occluding Wire in place. Failure to use the
Merit Occluding Wire will result in the
majority of therapeutic solution infusing
only from the end of the catheter and not
through the side ports.
Do not infuse into the Fountain Infusion
Catheter with any wire in place other than
the Merit Occluding Wire. Using a standard
guide wire or another manufacturer's
occluding wire could result in potential
catheter damage and/or patient injury.
The Fountain Infusion System should be
used only by physicians who have a thor-
ough understanding of infusion therapies
and the associated complications of those
infusion therapies.
Do not substitute or modify any compo-
nents of the system with a component man-
ufactured by any other manufacturer. Merit
Medical cannot guarantee the proper func-
tion of another manufacturer’s components.
Use only the Merit Access Plus
™ hemostasis
valve with this Fountain Infusion Catheter.
When introducing the Fountain Infusion
Catheter through a synthetic graft, an intro-
ducer sheath should be used. Damage to
the infusion catheter may occur if no intro-
ducer sheath is used.
D. W ARNING
A guide wire should never be advanced or
withdrawn against resistance. If a guide
wire is advanced where there is resistance,
it could cause vessel trauma and/or wire
damage. The cause of the resistance should
be determined utilizing fluoroscopy.
All components must be adequately flushed
with heparinized saline to displace air prior
to insertion into the body. Complications
may occur if air has not been displaced.
Correct placement of the guiding wire,
catheter, and occluding wire should be ver-
ified by fluoroscopy. Failure to use fluo-
roscopy could result in incorrect placement
resulting in patient injury or death.
Ensure that all connections are secure
before use. Do not over tighten as exces-
sive force may damage the product.
All therapeutic agents to be infused must be
used according to the manufacturer’s
instructions for use.
This device is intended for single use only.
Federal (USA) law restricts this device to sale
by or on the order of a physician.
Store in a cool dry place.
D ESCRIPTION OF D EVICE
The Fountain Infusion System consists of the
following components:
One (1) Fountain Infusion Catheter with
infusion holes at the distal section of the
catheter.
One (1) Occluding Wire which occludes the
distal end of the Fountain Infusion Catheter.
One (1) Check Relief Valve (CRV)
One (1) Access Plus hemostasis valve
One (1) 1 ml Medallion ® Infusion syringe
One (1) 20 ml Medallion Reservoir syringe
The above components may be packaged in a
single tray or may be packaged separately.
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