Radi PressureWire Aeris Manuals

1(17) Instruction for Use PressureWire® Aeris, 20828 Rev 0F; will be released as Rev 01 (Generated from approved Master Labeling Specification PW Aeris Rev 07F) Table of Contents CONTENTS DESCRIPTION 1. INDICATION FOR USE 2. CONTRAINDICATIONS 3. GENERAL WARNINGS 4. GENERAL PRECAUTIONS 5. ADVERSE EVENTS 6. PREPARATIONS FOR USE 7. DIRECTIONS FOR USE, CORONARY MEASUREMENTS 8. DIRECTIONS FOR USE, INTERVENTIONAL PROCEDURE 9. DIRECTIONS FOR USE, INTRACARDIAC MEASUREMENTS PRESSURE PERFORMANCE SPECIFICATION RADIO SIGNAL SPECIFICATION FCC STATEMENT TRANSPORT STORAGE TRANSMITTER LIGHT INDICATORS COMPLIANCE WITH REGULATORY REQUIREMENTS RoHS DECLARATION (for Chinese IFU only) PATENTS WARRANTY AND LIMITATIONS SYMBOLS WITH EXPLANATIONS CONTENTS - 0.014” (0.36 mm) guidewire - Disconnectable transmitter – to be used with the guidewire it is delivered with - Torque device DESCRIPTION (See Diagram 1) - PressureWire® 0.014” (0.36 mm) is a guidewire with a high fidelity sensor located just proximal to the 3 cm radiopaque shapeable tip. - PressureWire® has a nominal diameter of 0.014” (0.36 mm). - Refer to product label for guidewire length. - The signals from the sensor can be used for measurements of cardiac and intravascular blood pressure and estimations of Fractional Flow Reserve (FFR).