Ultreon™ Software

INDICATIONS FOR USE (APPLIES TO ALL)

The Ultreon™ 3.0 Software is intended to be used only with compatible OPTIS™ Next Imaging Systems. The OPTIS™ Next Imaging Systems with a compatible Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidate for transluminal interventional procedures. The Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

Applies to Ultreon™ 3.0 Software and OPTIS^™ Next Imaging Systems:

The OPTIS™ Next Imaging Systems are intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiology parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment to determine if therapeutic intervention is indicated.

CONTRAINDICATIONS (APPLIES TO ALL)

Use of the Ultreon™ 3.0 Software, Dragonfly OpStar™ Imaging Catheter and the OPTIS™ Next Imaging Systems is contraindicated where introduction of any catheter would constitute a threat to patient safety.

Contraindications include:

• Bacteremia or sepsis
• Major coagulation system abnormalities
• Patients diagnosed with coronary artery spasm
• Patients disqualified for coronary artery bypass graft (CABG) surgery
• Patients disqualified for percutaneous transluminal coronary angioplasty (PTCA)
• Severe hemodynamic instability or shock
• Total occlusion
• Large thrombus
• Acute renal failure
• Inability to tolerate systemic anticoagulation is a contraindication to use of OCT for coronary imaging.

LIMITATIONS

Applies to the Ultreon™ 3.0 Software and Optis™ Next Integrated Systems:

The system has no patient alarm functions. Do not use it for cardiac monitoring.

Applies to Ultreon™ 3.0 Software:

Only a qualified service representative can perform maintenance or service the system. Any attempt to open the system components by anyone other than a qualified Abbott Technical Service representative will void the warranty.

POTENTIAL ADVERSE EVENTS/COMPLICATIONS (APPLIES TO ALL)

The following potential adverse events may occur as a consequence of intravascular imaging and catheterization procedure:

• Abnormal heart rhythm or arrhythmias
• Acute myocardial infarction
• Allergic reaction to the contrast media or drug administered for the procedure
• Arterial dissection, injury, or perforation
• Bleeding
• Catheter access site reactions: inflammation, granuloma, or tissue necrosis
• Coronary artery spasm
• Death
• Embolism
• Hypotension
• Infection
• Myocardial ischemia
• Renal insufficiency or failure from contrast media use
• Repeat revascularization
• Thrombus formation, abrupt closure, or total occlusion
• Unstable angina

WARNINGS

Applies to Dragonfly OpStar™ Imaging Catheter and OPTIS™ Next Imaging Systems:

Leave the guide wire engaged with the Dragonfly™ Imaging Catheter at all times during use. Do not withdraw or advance the guide wire prior to withdrawing the Dragonfly™ Imaging Catheter.

Applies to the OPTIS^™ Next Imaging Systems:

Prior to use, please review the installed software’s User Manual and the Instructions for Use supplied with the OPTIS™ Integrated Next, Dragonfly™ Imaging Catheter, Wi-Box AO Transmitter, and PressureWire™ X Guidewire for more information on warnings, cautions, and setup instructions.

Applies to Dragonfly OpStar™:

Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.

The Dragonfly OpStar™ Imaging Catheter is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged. Do not reuse or re-sterilize. Any attempt to reuse or re-sterilize may compromise the structural integrity for this device. Adverse effects of using a non-sterile or re-sterilized imaging catheter may include, but are not limited to: local and/or systemic infection, mechanical damage, inaccurate results.

Note the product “Use by” date on the package.

Observe all advancement and movement of the Dragonfly OpStar™ Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage. To ensure proper placement, do not move the guide wire after the Dragonfly OpStar™ Imaging Catheter is in place.

If resistance is encountered during withdrawal of the Dragonfly OpStar™ Imaging Catheter: Stop manipulation and evaluate under fluoroscopy. If guide wire prolapse is observed, readvance the catheter, ensure the guide wire is coaxial to the monorail, and reattempt withdrawal. If the cause of resistance cannot be determined or mitigated, carefully remove the Dragonfly OpStar™ Imaging Catheter and guide wire as a unit from the patient and replace the Dragonfly OpStar™ Imaging Catheter and guide wire. Do not reuse the Dragonfly OpStar™ Imaging Catheter and guide wire.

Leave the guide wire engaged with the Dragonfly OpStar™ Imaging Catheter at all times during use. Do not retract or advance the guide wire prior to withdrawing the Dragonfly OpStar™ Imaging Catheter.

The Dragonfly OpStar™ Imaging Catheter should never be forced into lumens that are narrower than the catheter body or forced through a tight or heavily calcified lesion.

The Dragonfly OpStar™ Imaging Catheter should not be advanced through abnormally tortuous anatomy.

When advancing or retracting a Dragonfly OpStar™ Imaging Catheter with a monorail tip through a stented vessel, the Dragonfly OpStar™ Imaging Catheter may engage the stent between the junction of the Dragonfly OpStar™ Imaging Catheter and guide wire, resulting in entrapment of catheter/guide wire, catheter tip separation, stent dislocation, and/or vascular injury.

Do not remove the Dragonfly OpStar™ Imaging Catheter from the DOC until the procedure is complete to avoid a potential sterility breach.

Always verify that the Dragonfly OpStar™ Imaging Catheter has been properly prepared prior to inserting into vasculature.

The safety and effectiveness of the coated device has not been established, or is unknown, in vascular regions other than those specifically indicated.

Failure to abide by the warnings in this Instructions for Use might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.

PRECAUTIONS

Applies to Dragonfly OpStar™ Imaging Catheter:

Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which are not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.

Use the minimum flush rate and volume required to image the desired anatomy.

Refer to contrast media Instructions for Use for general warnings and precautions relating to contrast media.

Do not kink, sharply bend, pinch, or crush the Dragonfly OpStar™ Imaging Catheter at any time.

The Dragonfly OpStar™ Imaging Catheter has no user serviceable parts. Do not attempt to repair or alter any part of the catheter assembly as provided.

After use, the Dragonfly OpStar™ Imaging Catheter may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.

When using saline, heparinized saline is recommended.

Avoid abrasion of the hydrophilic coating. Use caution when manipulating, advancing and/or withdrawing these devices through needles, metal cannulas, stents, or other devices with sharp edges, or through tortuous or calcified blood vessels. Manipulation, advancement, and/or withdrawal past sharp or beveled edges may result in destruction and/or separation of the outer coating, which may lead to clinical adverse events, resulting in coating material remaining in the vasculature or device damage. This may result in adverse events requiring additional intervention.

The integrity and performance of the device coating can be negatively impacted by preparation with incompatible media or solvents. Please take note of the following important recommendations: Avoid wiping the device with dry gauze as this may damage the device coating. Avoid excessive wiping of the coated device. Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could negatively affect the safety and performance of the catheter.

Do not soak the device as it may adversely impact the hydrophilic coating on the catheter.

The Dragonfly OpStar™ Imaging Catheter must be purged prior to connection to the DOC to prevent damage to the imaging core.

Ensure that the Dragonfly OpStar™ Imaging Catheter tip marker has been properly identified and differentiated from the lens marker before administration of flush media and prior to performing the OCT reading.

Never attempt to attach or detach a Dragonfly OpStar™ Imaging Catheter to the DOC while the “lock” LED is lit.

WARNINGS (OCT)

Applies to Ultreon™ 3.0 Software and OPTIS^™ Next Integrated Systems:

Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.

Observe all advancement and movement of the Dragonfly™ Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage. To ensure proper placement, do not move the guide wire after the Dragonfly™ Imaging Catheter is in place.

If resistance is encountered during advancement or withdrawal of the Dragonfly™ Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the Dragonfly™ Imaging Catheter and guide wire as a unit from the patient.

The Dragonfly™ Imaging Catheter should never be forced into lumens that are narrower than the Dragonfly™ Imaging Catheter body or forced through a tight or heavily calcified lesion.

The Dragonfly™ Imaging Catheter should never be advanced through abnormally tortuous anatomy.

When advancing or retracting a Dragonfly™ Imaging Catheter with a monorail tip through a stented vessel, the Dragonfly™ Imaging Catheter may engage the stent between the junction of the Dragonfly™ Imaging Catheter and guide wire, resulting in entrapment of catheter/guide wire, catheter tip separation, stent dislocation, and/or vascular injury.

Refer to the contrast media Instructions for Use for general warnings and precautions relating to use of contrast media.

Applies to Ultreon™ 3.0 Software:

Prior to use, please review the Instructions for Use supplied with the Dragonfly™ Imaging Catheter for more information.

The Dragonfly OPTIS™ Imaging Catheter is not supported by Ultreon™ 3.0 Software for OPTIS™ Next Imaging Systems.

Ensure that no air is introduced into the system during the Dragonfly™ Imaging Catheter insertion.

Leave the guide wire engaged with the Dragonfly™ Imaging Catheter at all times during use. Do not withdraw or advance the guide wire prior to withdrawing the Dragonfly™ Imaging Catheter.

Before creating an OCT recording, review the Performing an OCT Procedure section for additional warnings and cautions.

Applies to OPTIS™ Integrated Imaging Systems:

Before performing an OCT recording, review the installed software’s User Manual for additional warnings and cautions.

PRECAUTIONS (OCT)

Applies to Ultreon™ 3.0 Software and OPTIS™ Next Integrated Systems:

Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which are not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.

When using saline, heparinized saline is recommended.

Use the minimum flush rate and volume required to image the desired anatomy.

Never attempt to attach or detach a Dragonfly™ Imaging Catheter to the DOC while the “lock” LED is lit.

The Dragonfly™ Imaging Catheter has no user serviceable parts. Do not attempt to repair or alter any part of the catheter assembly as provided.

Do not kink, sharply bend, pinch, or crush the Dragonfly™ Imaging Catheter at any time.

Applies to Ultreon™ 3.0 Software:

Follow all instructions, warnings, and cautions provided in the Patient Safety section.

All operators must be knowledgeable in performing OCT and physiological procedures prior to using the Ultreon™ 3.0 Software, OPTIS™ Next Imaging System, and the Dragonfly™ Imaging Catheter.

Monitor the OCT image for indications of the Dragonfly™ Imaging Catheter optical failure. If optical failure is suspected, remove the Dragonfly™ Imaging Catheter from the patient, press “Unload” on the drive motor and optical controller (DOC), detach the catheter, and replace it with a new one.

If the pullback triggers before the Flush Medium is injected, repeat the pullback.

To obtain accurate measurements, be sure the selection for the Flush Medium is the same as the medium in which you are imaging.

The Dragonfly™ Imaging Catheter must be purged prior to connection to DOC to prevent damage to the imaging core.

Do not insert or remove the Dragonfly™ Imaging Catheter while the DOC is scanning. Do not attempt to attach to or disconnect the catheter from the DOC while the “lock” LED is blinking as it could damage the catheter or the DOC. Refer to the Removing the Dragonfly™ Imaging Catheter section.

Take care in handling the Dragonfly™ Imaging Catheter to prevent breaking the fiber-optics within the catheter. While connecting, ensure the proximal catheter segment is straight and aligned with the DOC. Never attempt to connect and operate the catheter while the catheter remains coiled within the hoop.

If you want to make measurements on files that will be exported to standard formats, you must make the measurements BEFORE exporting the images. Using non-OCT software to measure standard format images will not produce accurate measurements.

Do not use images that have been exported for clinical decision making.

Artifacts may result in misrepresentation of L-mode data, so L-mode is not recommended for quantification of clinical information.

Deleted files cannot be restored. After files have been deleted, they can only be imported back to your system from your archived copies.

Restoring factory default settings resets ALL user-entered configuration values except the date and time. This button should be used only under the direction of qualified service personnel.

It is the user’s responsibility to confirm the lumen contours of all the frames within the reference segment, and to make adjustments, if necessary. Red frames indicate low confidence in the detected contours.

Applies to OPTIS™ Next Integrated Systems:

Follow all instructions, warnings, and cautions provided in Patient Safety section and in Operator Safety section.

Protect the exposed connector inside the DOC from fluids at all times. Fluid contact can disable the DOC and require service.

WARNINGS (FFR/RFR)

Applies to Ultreon™ 3.0 Software:

The heart rate and mean pressure values shown on the OPTIS^™ Next Imaging Systems are for reference only and are not intended to be used as the primary display.

Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.

Do not use the PressureWire™ X Guidewire if there are any signs of damage.

The system may place the point of index value at the wrong location due to pressure artifacts, for example: abnormal heartbeats, artifacts in AO (Pa) caused by flushing of the guiding catheter, or valve opening/closing. The physician should always confirm that the point selected by the system is a valid point for the calculation of index value.

PRECAUTIONS (FFR/RFR)

Applies to Ultreon™ 3.0 Software:

Before beginning a physiology procedure, review the Performing a Physiology Procedure section for additional warnings and cautions.

Patients with potential microvascular dysfunction and borderline index values should be interpreted with caution, and management strategies should be guided not only by pressure measurement, but also by possible supplementary clinical risk stratification and other tests.

If the cursor position has been saved, the index value is changed accordingly.

Do not turn on more than one PressureWire™ X Guidewire while the system is Searching/Connecting.

If the PressureWire™ X Guidewire is turned off or loses power at any point after equalization, you must remove it from the patient and re-zero it in its plastic hoop in heparinized saline before continuing. Refer to the PressureWire™ X Guidewire Instructions for Use for more information on troubleshooting the PressureWire™ X Guidewire.

If the equalization offset value is greater than or equal to 30, or less than or equal to -30, the system displays an alert icon in the Equalization measurement box. If the system displays the alert icon, try the following to reduce the EQ value:

‒   Confirm the AO transducer is positioned at the same height as the patient’s heart, and re-zero and re-equalize.

‒   If the alert remains, remove the PressureWire™ X Guidewire from the patient and re-zero it in its plastic hoop in heparinized saline.

To prevent incorrect measurement of the aortic pressure by the guiding catheter, causing an incorrect index value calculation:

‒   Flush any contrast remnants from the guiding catheter with heparinized saline.

‒   The insertion tool must be pulled back out of the hemostatic valve.

‒   The hemostatic valve must be closed during pressure measurement.

If you have zoomed in on a section of the recording, portions of the waveform are not displayed (the recording extends off screen). The physician should aways review the entire unzoomed recording before selecting the point for the calculation of the index value.

When closing the recording, the current cursor position and corresponding index value is saved. When the recording is re-opened, the cursor appears at the saved position. The cursor may then be moved, and the displayed

Pa and Pd pressures and index value change to reflect the new cursor position.

Do not use images that have been exported for clinical decision making.

Deleted files cannot be restored. After files have been deleted, they can only be imported back to your system from your archived copies.

Restoring factory default settings resets ALL user-entered configuration values except the date and time. This button should be used only under the direction of qualified service personnel.

Applies to OPTIS™ Next Integrated Systems:

CAUTION: Patients with potential microvascular dysfunction and borderline index values should be interpreted with caution, and management strategies should be guided not only by pressure measurement, but also by possible supplementary clinical risk stratification and other tests.

Before performing a physiological parameter procedure, review the installed software’s User Manual for additional warning and cautions.