Intended Use - St. Jude Medical PressureWire Aeris Instrucciones De Uso

PressureWire ™
en: Instructions for use
Content
PressureWire ™ Aeris
Sealed non-sterile outer box
Sealed sterile pouch
Packaging coil
PressureWire Aeris
Torque device
Transmitter
Quick Guide
Instructions for use
Store at room temperature in a dry and dark place.
1. Guidewire, refer to label for length
2. Flexible length, 31 cm
3. Shaft
4. Connector
5. Radiopaque tip, 3 cm
6. Sensor element
7. Hydrophilic coating
8. PTFE coating
Description
PressureWire is a 0.014" guidewire with an integrated sensor element at the tip to enable measurements 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 presentation of any physiological parameters, functions or in-
dices based on pressure or temperature, e.g. Fractional Flow Reserve (FFR).
Aeris ™
™ packages include:
9. Hydrophobic Polyimide insulators between
contact members
10. Torque device
11. PressureWire Aeris Transmitter
12. Function indicators
13. Switch
14. Close Cap
15. Open Cap
16. Cap
5