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.
SPECIFICATIONS:
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.