St.Jude Medical PressureWire Aeris Mode D'emploi page 6

Description
PressureWire is a 0.014" guidewire with an integrated sensor element at the tip to enable meas-
urements of physiological parameters. The guidewire is uniquely paired with a specific transmitter
for PressureWire Aeris. PressureWire is available in different lengths. Please refer to the label for
information about PressureWire length and thermo compatibility.
Intended use
PressureWire is designed to fit inside a percutaneous catheter for the purpose of directing the
catheter through a vessel. The signal output from the sensor is used for calculations and presenta-
tion of any physiological parameters, functions or indices based on pressure or temperature, e.g.
Fractional Flow Reserve (FFR).
Indications for use
PressureWire is indicated to direct a catheter through a blood vessel and to measure physiological
parameters in the heart and in the coronary and peripheral blood vessels.
Contraindications
PressureWire is contraindicated for use in the cerebral vasculature.
Warnings
▪ No modification of this device is allowed.
▪ PressureWire is supplied sterile. Discard PressureWire if the pouch is opened or damaged,
compromising the sterile barrier. PressureWire is designed for single use only and shall not
be reused or resterilized. Use of a non-sterile or resterilized PressureWire may result in, but
is not limited to:
– Local and/or systemic infection
– Mechanical damage
– Inaccurate readings
▪ Observe all PressureWire movements. Whenever PressureWire is moved or torqued, the tip
movement should be examined under fluoroscopy. Never push, withdraw or torque
PressureWire if it meets resistance or without observing corresponding movement of the tip;
otherwise vessel/ventricle trauma may occur.
▪ Torquing or excessive manipulation of PressureWire in a sharp bend, against resistance or
repeated attempts to cross a total vessel occlusion may:
– Damage and/or fracture PressureWire
– Cause dissection or perforation of blood vessels
– Cause vessel spasm
▪ When introducing PressureWire flush the catheter and administer anticoagulation as for a
standard catheterization procedure or clotting may occur.
▪ Do not use PressureWire in the ventricles if the patient has a prosthetic mechanical or biolog-
ical valve. It may result in damage to both the prosthesis and PressureWire, which may cause
injury or death.
▪ Use of PressureWire in conjunction with interventional devices with a short monorail may re-
sult in folded or fractured PressureWire.
▪ High frequency surgical device must not be used on a patient at the same time as
PressureWire.
Precautions
▪ PressureWire is a delicate instrument and should be handled carefully.
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