Page 1: Table Of Contents
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.
Page 2: Indication For Use
® Diagram 1: PressureWire 1. INDICATION FOR USE ® PressureWire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. 2. CONTRAINDICATIONS ® PressureWire is contraindicated for use in the cerebral vasculature.
Page 3: General Precautions
® Always advance or withdraw PressureWire slowly. Never push, withdraw or ® torque PressureWire if it meets resistance. 4. GENERAL PRECAUTIONS Federal (USA) law restricts this device to sale by or on the order of a physician. ® ® PressureWire is only intended to be used with PressureWire Receiver.
Page 4: Adverse Events
The PressureWire® Transmitter housing is protected against the effects of a ® discharge of a cardiac defibrillator. PressureWire readings may however be affected by defibrillation. Attempt recalibration ® of PressureWire after defibrillation according to “Recalibration” in the section Preparation for use. ®...
Page 5 ® Take care that the sensor element of PressureWire is just submerged but not under a column of liquid (the tray should be lying flat). Activate the receiver by pressing the CONNECT button. The receiver is now ® ready to connect to PressureWire (during 60 s), indicated by a flashing green light.
Page 6: Directions For Use, Coronary Measurements
7. DIRECTIONS FOR USE, CORONARY MEASUREMENTS 7.1. Engage the guiding catheter using standard practice. Flush the catheter. CAUTION: A guiding catheter with 6F (2 mm) size or larger should be used to prevent damping of the arterial pressure signal. Larger size should be considered when large interventional catheters are used.
Page 7: Directions For Use, Interventional Procedure
better handling. Carefully wipe and then dry the male connector before it is reconnected. WARNING: ® Torquing PressureWire against resistance or repeated attempts to cross a total vessel occlusion may cause damage and/or fracture, which may lead to a portion of ®...
Page 8: Directions For Use, Intracardiac Measurements
® 8.5 Reconnect PressureWire to the transmitter, taking care to gently and fully insert the male connector and to tighten the cap on the transmitter. 8.6 Treat the lesion using standard practice. 8.7 To evaluate the result of the intervention, withdraw the interventional device and perform pressure measurement.
Page 9: Pressure Performance Specification
WARNING: Avoid using PressureWire® in the ventricles if the patient has a prosthetic mechanical valve. PressureWire® may become trapped and disrupt the function of the valve, leading to serious injury or death. CAUTION: A standard 0.035” J-shaped guidewire is recommended to advance the catheter and to give support when crossing heart valves.
Page 10: Radio Signal Specification
(1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. WARNING - Changes or modifications not expressly approved by Radi Medical Systems AB could void the user´s authority to operate the equipment. ENVIRONMENTAL CONDITION Ambient temperature: 15-35°C...
Page 11: Transmitter Light Indicators
COMPLIANCE WITH REGULATORY REQUIREMENTS Hereby, Radi Medical Systems AB, declares that this PressureWire® is in compliance with the essential requirements and other relevant provisions of Medical Device Directive (93/42/EEC), Radio and Telecommunications Terminal Directive...
Page 12 Immunity test IEC 60601 Compliance Electromagnetic Test level level environment - guidance Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete discharge (ESD) ±8 kV air ±8 kV air or ceramic tile. If floors are covered IEC 61000-4-2 with synthetic material, the relative humidity should be at least 30%.
Page 13 IEC 61000-4-6 150 kHz to 80 MHz Radiated RF 3 V/m 3 V/m d = 1,2√ P 80 MHz to 800 MHz IEC 61000-4-3 80 MHz to 2,5 GHz d = 2,3√P 800 MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended...
Page 14: Rohs Declaration (For Chinese Ifu Only)
Radi shall not be liable to any person or entity for any medical expenses or any direct, incidental or consequential damages caused by any use, defect, failure or malfunction of the product, whether a claim for such damages is based upon warranty, contract, tort or otherwise.
Page 15 Designed, developed and manufactured by: Radi Medical Systems AB Palmbladsgatan 10, SE-754 50 Uppsala, Sweden Tel + 46 (0) 18 16 10 00, Fax: 46 (0) 18 16 10 99 e-mail: radi@radi.se Radi Medical System contacts and further information: www.radi.se 15(17)
Page 16: Symbols With Explanations
SYMBOLS WITH EXPLANATIONS: Caution, (Attention consult accompanying documents) Consult operating instructions Expiry date (2 years from manufacturing date) Contents of the package Catalogue number Lot number. Quantity Type CF equipment Equipment includes RF transmitter Electrostatic sensitive device Do not use if package is damaged. For single use only.
Page 17 The transmitter contains silver oxide button type batteries with in total < 2% mercury, allowed to be put on the market according to the battery directive 2006/66/EG. The signal performance requires the batteries to be permanently affixed and the transmitter to be sealed, which, according to article 11 in the same directive, exclude the batteries from the requirement to be possible to remove.

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