9(17)
WARNING:
Avoid using PressureWire® in the ventricles if the patient has a prosthetic
mechanical valve. PressureWire® may become trapped and disrupt the function of
the valve, leading to serious injury or death.
CAUTION:
A standard 0.035” J-shaped guidewire is recommended to advance the catheter and
to give support when crossing heart valves. Never use PressureWire® for this
purpose.
9.1 Use a standard 0.035” J-shaped guidewire to position a multipurpose catheter in
the heart at the position of interest, follow standard clinical practice depending on
application.
9.2 With the catheter securely in place, replace the standard guidewire with
PressureWire®.
9.3 Insert the distal tip of PressureWire® into the hemostatic valve and then advance
the wire into catheter.
9.4 Advance PressureWire® into the position of interest.
WARNING:
Observe all PressureWire
®
movement. Whenever PressureWire
®
is moved or
torqued, the tip movement should be examined under fluoroscopy.
9.5 Pull back the catheter to a stable position outside the heart valve, leaving only
PressureWire® at the measurement position.
CAUTION:
Whenever absolute blood pressure measurements are obtained, the pressure
registered by the catheter and PressureWire® should be properly matched. For this
purpose the catheter should have a residual lumen large enough to prevent damping
of the corresponding intracardiac pressure.
PRESSURE PERFORMANCE SPECIFICATION
Operating pressure:
-30 to +300 mmHg
Zero Thermal Effect:
0.3 mmHg/°C
Sensitivity Thermal Effect:
0.3%/°C
Zero drift:
< 7mmHg/h
Total Accuracy for the combination
of PressureWire
®
and PressureWire® Receiver:
±1mmHg plus ±1% of reading (over the
pressure range – 30mmHg to 50mmHg)
±3% of reading (over the range 50mmHg to
300mmHg)
