Directions For Use, Interventional Procedure - Radi PressureWire Aeris Manual

better handling. Carefully wipe and then dry the male connector before it is
reconnected.
WARNING:
®
Torquing PressureWire against resistance or repeated attempts to cross a total
vessel occlusion may cause damage and/or fracture, which may lead to a portion of
®
PressureWire separating from the tip.
NOTE: To calculate Fractional Flow Reserve (FFR) apply maximum hyperemic
stimulus according to clinical standard practice.
CAUTION:
Failure to achieve maximum coronary and myocardial hyperemia may result in invalid
FFR.
CAUTION:
®
Do not measure pressure when the sensor element of PressureWire is in sharp
curves, since this might result in pressure artefacts.
WARNING:
®
Excessive manipulation when sensor element (D) or tip of PressureWire is located
in sharp bend may cause damage or tip fracture. If the guiding catheter is in an
anatomically severe or sharp bend, for example a tortuous subclavian artery or
adjacent vessel position, the junction between the shaft and the flexible distal section
of the wire (E), 31 cm from the tip, may be vulnerable to kinking or fracture. Avoid
®
use of PressureWire via a radial or brachial approach unless this approach is based
on medical necessity.
If a decision is taken to continue with an interventional procedure, follow these
instructions:

8. DIRECTIONS FOR USE, INTERVENTIONAL PROCEDURE

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.
8.1 Inspect and prepare the interventional device according to the manufacturer's
instructions.
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8.2 Disconnect the transmitter from PressureWire , then remove the torque device by
loosening the screw and gently withdraw it.
8.3 Carefully advance the interventional device over PressureWire® male connector
and proceed according to standard clinical practice.
8.4 Carefully wipe and then dry the male connector before it is reconnected.
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