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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).
