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INFUSION SYSTEM - 5 FRENCH
Intended Use of Product
A. Indications
The Fountain Infusion System with Squirt is intended to
administer infusions of various therapeutic solutions into
the peripheral vasculature of a patient.
B. Contraindications
The Fountain Infusion System with Squirt is contraindicated
for use in the coronary vasculature.
The Fountain Infusion System with Squirt is contraindicated
for use during magnetic resonance imaging.
C. Cautions
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 with Squirt should be used
only by physicians who have a thorough understanding
of infusion therapies and the associated complications of
those infusion therapies.
Do not substitute or modify any components of the system
with a component manufactured by any other manufac-
turer. Merit Medical cannot guarantee the proper function
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 introducer sheath should be used.
Damage to the infusion catheter may occur if no introducer
sheath is used.
D. Warning
A guide wire should never be advanced or withdrawn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 heparin-
ized saline to displace air prior to insertion into the body.
Complications may occur if air has not been displaced. Cor-
rect 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 damage the product.
English
All therapeutic agents to be infused must be used accord-
ing 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.
WIRE
PROTECTOR
CAP
OCCLUDING
WIRE
ACCESS
PLUS
HEMOSTASIS
VALVE
Description of Device
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 distal 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
One (1) Wire Protector Cap
The above components may be packaged in a single tray or
may be packaged separately.
INSTRUCTIONS FOR USE
Flushing and Debubbling the System
1. Flush the Fountain Infusion Catheter with sterile, hepa-
rinized normal saline so that all the air has been completely
removed.
SQUIRT FLUID
DELIVERY SYSTEM
FOUNTAIN INFUSION CATHETER
RADIOPAQUE
MARKERS
20 ml RESERVOIR SYRINGE
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