St Jude Medical 01080410 PressureWire® Aeris User Manual

St Jude Medical Systems AB PressureWire® Aeris Users manual

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Users manual

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).
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Document ID909001
Application IDix4slL0VbEU/idtaln2nLA==
Document DescriptionUsers manual
Short Term ConfidentialNo
Permanent ConfidentialNo
SupercedeNo
Document TypeUser Manual
Display FormatAdobe Acrobat PDF - pdf
Filesize22.76kB (284530 bits)
Date Submitted2008-03-03 00:00:00
Date Available2008-07-09 00:00:00
Creation Date2008-02-06 16:13:52
Producing SoftwareAcrobat Distiller 5.0.5 (Windows)
Document Lastmod2008-02-06 16:13:52
Document TitleMicrosoft Word - IFU PressureWire Aeris 20828 Rev 0F.doc
Document CreatorPScript5.dll Version 5.2.2
Document Author: mroos
FCC ID Filing: U4L01080410

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