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INFUSION SYSTEM - 4 FRENCH & 5 FRENCH
I N S T R U C T I O N S F O R U S E
INTENDED USE OF PRODUCT
INDICATIONS
The Fountain ValveTip Infusion System is intended to administer infusions of various
therapeutic solutions into the peripheral vasculature of a patient.
CONTRAINDICATIONS
The Fountain ValveTip Infusion System is contraindicated for use in the coronary
vasculature. The Fountain ValveTip Infusion System is contraindicated for use during
magnetic resonance imaging.
CAUTIONS
Do not use the Fountain ValveTip Infusion System with a power injector. Damage to the
catheter or hemostasis valve may occur.
Do not infuse into the Fountain ValveTip Infusion Catheter with any wire in place. Using
a standard guide wire or any manufacturer's occluding wire could result in potential
catheter damage and/or patient injury.
The Fountain ValveTip Infusion System 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 man-
ufactured by any other manufacturer. Merit Medical cannot guarantee the proper
function of another manufacturer's components. Use only the Merit Access Plus™
hemostasis valve with this Fountain ValveTip Infusion Catheter.
When introducing the Fountain ValveTip 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.
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A guide wire should never be advanced or withdrawn against resistance.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 dam-
age. 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 and catheter 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.
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.
REUSE PRECAUTION STATEMENT
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing
or resterilization may compromise the structural integrity of the device and/or lead
to device failure which, in turn, may result in patient injury, illness or death. Reuse,
reprocessing or resterilization may also create a risk of contamination of the device and/
or cause patient infection or cross-infection, including, but not limited to, the transmis-
sion of infectious disease(s) from one patient to another. Contamination of the device
may lead to injury, illness or death of the patient.
: Federal (USA) law restricts this device to sale by or on the order of a
physician.
Store in a cool dry place.
ENGLISH
DESCRIPTION OF DEVICE
The Fountain ValveTip Infusion System consists of the following components:
One (1) Fountain ValveTip Infusion Catheter with infusion holes at the distal section
of the catheter.
One (1) Access Plus hemostasis valve
The above components may be packaged in a single tray or may be packaged sepa-
rately.
HEMOSTASIS
PRIMING VOLUME
The approximate system priming volume for each catheter are as follows:
-
45cm catheter – 1.0ml
-
90cm catheter – 1.5 ml
-
135cm catheter – 2.0ml
INSTRUCTIONS FOR USE
FLUSHING AND DEBUBBLING THE SYSTEM
1. Flush the Fountain ValveTip Infusion Catheter with sterile, heparinized normal
saline so that all the air has been completely removed.
Warning: Complications may occur if all the air has not been removed prior to
insertion into the body.
CATHETER INSERTION
2. Place the Fountain ValveTip Infusion Catheter into position under fluoroscopic
guidance following standard hospital protocol. The two radiopaque marker
bands on the Fountain ValveTip Infusion Catheter indicate the infusion segment
where side hole infusion occurs. (Figure 1)
Note: The Fountain ValveTip Infusion Catheter will pass through a standard 4F or
5F introducer sheath and over a 0.035" (0.89 mm) guide wire. Use a 4F introduc-
er sheath with the corresponding 4F Fountain ValveTip Infusion System, and a 5F
introducer sheath with the corresponding 5F Fountain ValveTip Infusion System.
3. Remove the 0.035" placing guide wire. Proceed with infusion using standard
hospital protocol, without the use of an occluding wire.
Warning: A guide wire should never be advanced or removed if resistance is
present. If the guide wire is advanced against resistance, it could potentially
create vessel trauma and/or wire damage. The cause of the resistance should
be determined under fluoroscopy. Take any necessary actions to correct the
problem.
ACCESS
PLUS
VALVE
FOUNTAIN INFUSION CATHETER
RADIOPAQUE
MARKERS
FIGURE 1
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