Storage And Handling; Disclaimer Of Warranty - Opsens OptoWire Deux Mode D'emploi


When shaping the distal end, do not shape with a sharp edged instrument. Use the minimum force needed so that the coil is not damaged. Inspect the coil and
OptoWire for damage after shaping and before using.

Do not flex the proximal end of the OptoWire. Excessive flexing resulting kink may affect the OptoWire performance resulting in inaccurate pressure reading.
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Do not attempt to straighten a guidewire that has been kinked.
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In both diagnostic and interventional procedures clean OptoWire thoroughly with heparinized saline before and after each insertion.
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The accuracy of the diagnostic information may be affected, ensure the following but not limited to:
o
Proper selection of guide catheter size, positioning and type.
o
Ensure optimal aortic pressure waveform before FFR procedure.
o
Proper procedure and positioning of the OptoWire sensor element outside the guide catheter to achieve correct equalization.
o
Optimal maximum coronary and myocardial hyperaemia.
o
Unaffected blood flow by interventional devices, such as balloon catheters.
o
Free from contact with atrial or ventricular walls which may result in pressure artefacts.
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Confirm the compatibility of the guidewire diameter with the interventional device before actual use.
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OptoWire may become entangled in one or more stent struts when advancing into a stented vessel where the stent is not fully apposed against the vessel wall. This may
result in entrapment, shredding of the OptoWire and/or stent dislocation.

Avoid having OptoWire to come into contact with stent struts when advancing the OptoWire into a stented vessel. This may result in entrapment, shredding of the
OptoWire and/or stent dislocation.

Use caution when advancing or retracting the OptoWire through a deployed stent as use of this technique carries additional patient risks and may cause OptoWire
damages, stent entanglement or stent dislocation.
INSTRUCTIONS FOR USE:
Preparation for and Initial use

Check to ensure package has not been opened or damaged.

Open sealed pouch and remove tray using sterile technique and place the tray flat on the sterile field.
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Connect the FOIC connector to the OptoMonitor Handle Unit.
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Remove the Gauge Factor Connector from the plastic tray and connect to the OptoMonitor Handle unit.
Automatic Zero to atmosphere
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The OptoWire will ZERO automatically as soon as the OptoWire FOIC connector is inserted into the OptoMonitor Handle Unit. Insert the matching Gauge Factor
Connector into the OptoMonitor Handle Unit.

In the event of "No Signal, check OptoWire connection", verify that the proximal end of the guidewire is fully inserted into the Handle.
Zero is not performed if the OptoWire pressure varies: OptoWire must be pulled out of guiding catheter for zeroing.
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Once zeroed, flush the working length of the OptoWire with saline solution and carefully remove the guidewire from the tray.

If indicated, the guidewire distal tip may be shaped using standard tip-shaping practices. Do not use a shaping instrument with a sharp edge. After shaping, verify that
there is no damage to the guidewire before using it.
Equalization
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Advance the OptoWire through guiding catheter using the appropriate guidewire introducer.
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Insert and position the pressure sensor (3.5 cm from tip) just outside of the guiding catheter opening in using the radiopaque marker of the interventional device to
confirm position (radiopaque section is 3.5 cm of the entire tip).

Flush the guiding catheter repeatedly with normal saline because contrast medium may dampen the catheter pressure waveform.
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Verify aortic transducer's position and ensure optimal aortic pressure waveform.
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Equalize. Verify the pressure from the guiding catheter and the OptoWire are equal.
Pressure Measurement and Induce Hyperemia
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Advance the OptoWire tip under fluoroscopy using contrast injections to verify location.
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Steer the pressure sensor to region of interest. Ensure the OptoWire tip is rotating freely and no resistance is felt when torque is applied.
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Induce maximal hyperemia according to standard clinical procedure.
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Perform pressure measurements according to standard clinical procedure. If needed, a pullback curve may be performed.
Interventional procedure
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Rotate the Handle locking mechanism to unlock position and retrieve the OptoWire gently from the Handle and remove the torque device.
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Track the interventional device over the OptoWire while taking care not to kink the proximal portion of the OptoWire.
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Proceeds according to manufacturer's instructions.
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To get post procedure pressure measurement, gently reinsert the OptoWire into its Handle and rotate the locking mechanism to the locked position to obtain pressure
measurement. Clean the proximal end of the OptoWire with heparinized saline if needed.
End of procedure – Pullback signal drift check and disposal

Carefully withdraw OptoWire after procedure. Position the pressure sensor (3.5 cm from tip) just outside of the guiding catheter opening. Verify the pressure from the
guiding catheter and the OptoWire are equal.

Handle and dispose OptoWire following standard solid biohazard waste procedures and in accordance with medical practices and applicable, local, state and federal
laws and regulations.

STORAGE AND HANDLING:

Store in a dry, dark, cool place.

DISCLAIMER OF WARRANTY

Although the guidewire OptoWire Deux hereafter referred to as "Product" has been manufactured and designed under carefully controlled conditions, Opsens Inc. has no control
over the conditions under which this Product is used. Opsens Inc., therefore disclaims all warranties, both express and implied, written or oral, with respect to the Product including,
but not limited to, any implied warranty as to the condition, quality, durability, performance, merchantability or fitness for a particular purpose. Opsens Inc. shall not be liable to any
person or entity for any medical expenses, any loss or injury to a party's profits or goodwill or any direct, incidental, consequential, special, punitive or exemplary damages caused by,
arising from or related to any use, defect, failure or malfunction of the Product, whether a claim for such damages is based upon warranty, contract, tort or otherwise. No person has
any authority to bind Opsens Inc. to any representation or warranty with respect to the Product. The exclusions and limitatio ns set out above are not intended to, and should not be
construed so as to contravene mandatory provisions of applicable law. If any part or term of this Disclaimer of Warranty is held to be illegal, unenforceable or in conflict with applicable
law by a court of competent jurisdiction, the validity of the remaining portions of this Disclaimer of Warranty shall not be affected, and all rights and obligations shall be construed
and enforced as if this Disclaimer of Warranty did not contain the particular part or term held to be invalid.
This product, and the use thereof, may be covered by the following U.S. and international patents: US7259862, US7689071, US 9052466, CA2576978, CA2808202, CA2591787,
100451694C, JP5264172, JP4994244. Other U.S. and international patents pending.
ADDITIONAL QUESTIONS REGARDING THIS PRODUCT SHOULD BE DIRECTED TO:
Manufactured By: Opsens Inc 750 boul. du Parc Technologique, Quebec QC G1P 4S3 Canada T. :+1.418.781.0333 - www.opsens.com
Authorized European Representative: MDSS GmbH Schiffgraben 41 30175 Hannover, Germany
Australian Sponsor: Emergo Australia Level 20, Tower II Darling Park 201 Sussex Street Sydney NSW 2000 Australia
2-v7 LBL-2005-07-v6 OW DEUX IFU F1011 Rev.2019 05 5