St. Jude Medical Wi-Box AO Instrucciones De Uso página 6

Indications for Use
PressureWire™ Net is indicated to condition a physiological signal from the cardiovascular system,
transmit and receive via radiofrequency, and recondition the signal to its original format so that it
can be displayed. The physiological signal can also be distributed via cable.
Intended Use
PressureWire™ Net is intended to condition physiological signals from measuring devices
(PressureWire™ guidewire and an external pressure transducer), transmit and receive via
radiofrequency, and reconditions the signals to its original format so that those can be displayed on
and/or recorded in a receiving device (RadiAnalyzer™ Xpress or other monitor systems). The
physiological signals can also be distributed via cable.
General Warnings
Wireless transmitter and RadiAnalyzer™ Xpress pressure output ports are not designed nor

intended for vital signs monitoring.
Modification of this equipment is not allowed.

General Precautions
Federal (USA) law restricts distribution and sales of this device to sale by or on the order of a

physician.
Handle this device in accordance with medical practice and applicable local, state and federal

laws and regulations.
Do not use this device if it has been subject to damage.

If this device has been subject to accidental wetting, wipe off and perform leakage current

measurement and functional test.
Software upgrade shall not be performed during a clinical procedure.

Installation
Normal Operation
NOTE
The Wi-Box™ AO transmitter needs to be installed in a place that ensures adequate

radio transmission with receiving unit. Radio range is reduced by objects and walls,
keep the Wi-Box AO transmitter and receiving unit in a line of sight wherever
possible.
High frequency surgical equipment shall not be used in the close proximity of the

device since this could influence the performance of the device.
Mount the Wi-Box™ unit vertically on or close to the cathlab table using the enclosed
1.
mounting details.
The cable connectors shall be facing downward to minimize stress on cabling and connectors
and to protect the unit from ingression of fluids.
2