Merit Medical Fountain 4 French with Squirt - Manual (Page 3)

I NTENDED U SE OF P RODUCT
A. I NDICATIONS
The Fountain Infusion System with Squirt is
intended to administer infusions of various ther-
apeutic solutions into the peripheral vasculature
of a patient.
B. C ONTRAINDICATIONS
The Fountain Infusion System with Squirt is con-
traindicated for use in the coronary vasculature.
The Fountain Infusion System with Squirt is con-
traindicated 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 hemo-
stasis 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 with Squirt should
be used only by physicians who have a thorough
understanding of infusion therapies and the asso-
ciated complications of those infusion thera-
pies.
Do not substitute or modify any components of
the system with a component manufactured by
any other manufacturer. Merit Medical cannot
guarantee the proper function of another manu-
facturer’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 introducer sheath
should be used. Damage to the infusion catheter
may occur if no introducer sheath is used.
D. W ARNING
A guide wire should never be advanced or with-
drawn 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 uti-
lizing 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 verified by fluoroscopy. Failure to use
fluoroscopy could result in incorrect placement
resulting in patient injury or death.
Ensure that all connections are secure before use.
Do not over tighten as excessive force may dam-
age 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 with Squirt 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 dis-
tal end of the Fountain Infusion Catheter.
One (1) Access Plus hemostasis valve
One (1) 20 ml Medallion ® Reservoir syringe
One (1) Squirt Fluid Delivery System
The above components may be packaged in a single
tray or may be packaged separately.
E1