3(17)
- Always advance or withdraw PressureWire
®
slowly. Never push, withdraw or
torque PressureWire
®
if it meets resistance.
4. GENERAL PRECAUTIONS
- Federal (USA) law restricts this device to sale by or on the order of a
physician.
- PressureWire
®
is only intended to be used with PressureWire
®
Receiver.
- PressureWire
®
shall not be used with any other transmitter than the one which
it is delivered with, or unreliable readings will be registered.
- Refer to instructions supplied with any interventional devices to be used in
conjunction with PressureWire
®
for their intended uses, contraindications and
potential complications.
- Do not use PressureWire
®
with atherectomy catheters. These systems may
cause PressureWire
®
to fold back upon itself and become lodged in the
atherectomy catheter. If this occurs, withdraw both the atherectomy catheter
and PressureWire
®
simultaneously.
- PressureWire
®
does not give sufficient support for guiding catheter exchange.
- Do not use with interventional devices with a too short guidewire rail length as
PressureWire
®
may fold or fracture during manipulation.
- Confirm the compatibility of PressureWire
®
diameter with the interventional
device before actual use.
- Free movement of the guidewire within the interventional device is an
important feature of a steerable guidewire system because it gives the user
valuable tactile information. Test the system for any resistance prior to use.
- Adjust or replace the hemostatic valve with an adjustable valve if it is found to
inhibit guidewire movement.
- When PressureWire® is disconnected from the transmitter during the
procedure make sure the male connector does not come into contact with
conductive surfaces thus avoiding unintentional connection with other
equipment.
- False pressure readings may occur if the male connector is:
- not dry, clean and free of coagulated blood.
- not fully inserted into the bottom of the transmitter (indicated by yellow
light).
- bent or damaged.