6(17)
7. DIRECTIONS FOR USE, CORONARY MEASUREMENTS
7.1. Engage the guiding catheter using standard practice. Flush the catheter.
CAUTION:
A guiding catheter with 6F (2 mm) size or larger should be used to prevent
damping of the arterial pressure signal. Larger size should be considered when
large interventional catheters are used.
7.2. Carefully insert the distal tip of the guidewire into the hemostatic valve of
the Y connector and then advance the wire into the catheter.
7.3. Position the sensor element of PressureWire
®
just outside of the tip of the
guiding catheter.
7.4. Pull back the insertion tool out of the hemostatic valve.
7.5. Tighten the hemostatic valve.
7.6. Place the aortic pressure transducer at the same height as the patient´s
heart. Make sure there is no remaining contrast fluid in the catheter, flush if
necessary.
7.7. Verify that the aortic pressure from the guiding catheter and the
PressureWire
®
pressure are similar.
7.8. To remove any residual pressure difference between aortic and
PressureWire
®
pressure use the equalization function on the Cathlab
monitor system or use the plus (+) and minus (–) buttons on
PressureWire
®
Receiver. Refer to the Instructions for use for the Cathlab
monitor or the Instructions for use for PressureWire
®
Receiver.
WARNING:
When introducing the guidewire, confirm that the catheter tip is free within the
vessel lumen and not against the vessel wall. Failure to do so may result in vessel
trauma upon guidewire exit of the catheter. Use the radiopaque marker of the
catheter to confirm position.
7.9. Advance
PressureWire
®
out of the guiding catheter. Use the torque device
to steer PressureWire
®
to the desired position and perform pressure
measurement.
WARNING:
Observe all PressureWire
®
movement. Whenever PressureWire
®
is moved or
torqued, the tip movement should be examined under fluoroscopy.
CAUTION:
When difficult to reach a desired position, PressureWire
®
may be disconnected for
