Merit Medical IntelliSystem 25 Inflation Device - Manual

DESCRIPTION:
The Merit IntelliSystem25 Inflation Device and Fluid
Dispensing Syringe is a 20ml disposable syringe with an
integral pressure transducer, threaded plunger assembly
with lock/release bar, a flexible high pressure extension
tube, and a three-way medium pressure stopcock. The
IntelliSystem25 is designed to generate and monitor
pressures and dispense fluid with each turn of the handle.
INSTRUCTIONS FOR USE:
This device is intended to be used only with the
IntelliSystem Monitor. Read IntelliSystem
Monitor Instructions For Use before use.
Before use, inspect the device and packaging to verify that
no damage has occurred as a result of shipping.
NOTE: To generate and monitor pressures over 20 ATM,
20 BAR or 300 PSI the IntelliSystem Monitor must have
6.0 version software or greater.
CAUTION: Federal (U.S.A.) law restricts this device to use
by or on the order of a physician.
NOTE: The IntelliSystem25 syringe is packaged with a
perforated bag over the cable connectors. Leave the bag in
place until the syringe has been prepared with fluid. This
will prevent fluid contamination on the cable connectors.
WARNING: This device should not be used in the
presence of flammable anesthetics.
Manufacturer: Merit Medical Systems, Inc.
South Jordan, Utah 84095 U.S.A.1-801-253-1600
U.S.A. Customer Service 1-800-356-3748
Authorized Representative:
Merit Medical Ireland Ltd
Parkmore Business Park West, Galway, Ireland
400646002/B
ID 070110
PRIMING WITH PRIMELOK TM
The PrimeLok allows purging of air and
excess fluid without squeezing the
lock/release mechanism. The
IntelliSystem25 is packaged with
the PrimeLok and with the
lock/release mechanism in the
disengaged position.
1. To engage PrimeLok, squeeze
handle and slide PrimeLok into
plunger.
2. To prep syringe, simply aspirate up
to 20ml of contrast solution or fluid
to be dispensed into the syringe by
pulling back on the plunger handle.
CAUTION: Inspect the syringe
tubing and stopcock (if used)
to insure that there is no air in the
system.
3. Push handle against table to
remove air in syringe.
4. To disengage squeeze handle and
slide PrimeLok out of barrel. This will
allow the plunger to lock in position
and is now ready for use.
NOTE: The PrimeLok must be
disengaged before pressure can be
maintained by the lock/release
mechanism.
ATTACHING THE INFLATION DEVICE TO THE BALLOON:
This inflation device is used to inflate and deflate an
angioplasty balloon or other interventional device, in
conjunction with the Merit IntelliSystem Monitor and to
measure the pressure within the balloon. Refer to the
IntelliSystem Monitor’s User Manual for additional
information on its function.
NOTE: Refer to the manufacturer’s directions
accompanying the balloon dilatation catheter or other
interventional device for specific information on use,
maximum inflation pressure, precautions, and warnings
for that device.
1. Prepare and test the balloon catheter according to the
catheter manufacturer’s directions for use.
2. Create a fluid-fluid connection between the catheter and
the inflation syringe extension tube and connect the luer
connectors securely.
3. Squeeze the lock/release bar and pull back on the
plunger handle to apply a vacuum to the balloon when
indicated in the instructions for use of the interventional
device.
BALLOON INFLATION AND DEFLATION:
1. To inflate the balloon, squeeze the lock/release bar
allowing the plunger to return to zero pressure as
displayed on the IntelliSystem Monitor. Release grip on
the lock/release bar, locking the plunger into position. To
increase pressure, rotate the plunger clockwise until the
desired inflation pressure is reached. The lock mechanism
maintains the pressure.
NOTE: Loss of pressure may indicate a leak in the system.
Check connections.
2. To deflate the balloon, squeeze the lock/release bar and
pull back to generate a negative pressure. Release grip on
the lock/release bar to lock the plunger in the negative
pressure position.
S P E C I F I C A T I O N S :
Fluid Dispensed: 0.48 ±.07ml fluid dispensed for
each 360˚ clockwise turn of the
syringe plunger handle
FLUID DISPENSING INDICATIONS AND USAGE:
This device is intended for use by healthcare
professionals to dispense fluids to the body from the
IntelliSystem25 Syringe and monitor the pressure of that
fluid when used with the IntelliSystem Monitor.
1. To slowly dispense fluids to the body rotate the
plunger clockwise until the desired fluid is injected. The
injection pressure and time will be displayed on the
Monitor .
2. To rapidly dispense fluids to the body squeeze the
lock/release bar while pushing the plunger forward.
3. A negative pressure may be generated by squeezing
the lock/release bar and pulling back the plunger. Release
grip on the lock/release bar to lock the plunger in the
negative pressure position.
CAUTION: This syringe is capable of generating high fluid
pressures in a "closed" fluid system. The volume change
of fluid dispensed may not be accurate due to compliance
of the plastic components as pressure changes.
CAUTION: If applied pressure does not indicate on gauge/
digital display, discontinue use immediately and replace it
with a new unit.
I N S T R U C T I O N S F O R U S E
U.S. Patent Nos. 5,135,488 5,711,302.
Other U.S. and Foreign Patents Pending.
Inflation Device and
Fluid Dispensing Syringe
ENGAGE
PRIMELOK
ENGAGED PRIMELOK
DISENGAGE
PRIMELOK