ILUMIEN™ PCI Optimization System How to Use in FFR and OCT Procedures This presentation describes how to set up the ILUMIEN PCI Optimization System in order to perform FFR (Fractional Flow Reserve) and OCT (Optical Coherence Tomography) procedures.

ILUMIEN™ PCI Optimization System FFR Procedure

FFR Procedure – Select Cath Lab Room Select cath lab room by clicking on the desired icon. The rooms and detected Wi-Box (turned on and within radio range from ILUMIEN) are indicated in green. Pre-installed Wi-Box that are not detected (turned off or out of radio range) are indicated in red with crossed-out radio signal symbol. You have the possibility to rename the rooms: 1, 2, 3…or names of the cath labs. IMPORTANT: Every Wi-Box has a serial number (S/N) of 8 digits. This is the Wi-Box “Identity Number.” The first time you install a Wi-Box, the serial number is connected to a room (cath lab) and the room can then be renamed (1, 2, 3... or Blue, Green, etc.). If you decide to move a Wi-Box to another cath lab, you must connect it to a new room profile.

Equipment for FFR Calculation PressureWire™ Aeris™ Hyperemia To measure FFR, in addition to the wireless Wi-Box and ILUMIEN, you need PressureWire Aeris and a drug to induce hyperemia.

Hyperemia Hyperemia is a pre-requisite for FFR. A high volume infusion pump is required for IV administration of hyperemic drugs 140 Check the literature for suitable drugs and dosages.

FFR Procedure – Calibrate Aortic Pressure Follow on-screen step-by-step instructions. The first step is to open the aortic (AO) transducer to air and click Zero Pa. Close stop cock to resume the aortic signal on the screen. Note: by pressing the tubing to the AO transducer, make sure you have connected the AO transducer (Wi-Box) to the correct cath lab (you will see a pressure response on the red waveform).

FFR Procedure – Prepare PressureWire™ Aeris™ Remove the pouch from the box Remove PressureWire™ Aeris™ Place the tray flat Follow printed illustrations on the tray to prepare PressureWire Aeris for use Remove the pouch from the packaging box and open it using sterile technique. Remove PressureWire Aeris, still attached to the packaging tray. Place the tray flat on the sterile field. Follow printed illustrations on the tray to prepare PressureWire Aeris for use.

FFR Procedure – Prepare PressureWire™ Aeris™ Flush coil with saline Fill coil with saline; take care not to expose PressureWire transmitter to fluids. Loosen torque device Make sure to pull torque device forward along the wire; do not bend it loose.

FFR Procedure – Prepare PressureWire Aeris Open holding flaps Carefully tear open the flaps holding PressureWire transmitter to the tray. Remove PressureWire transmitter Lift PressureWire transmitter up and place it on the bed next to the tray without removing the wire from coil. Make sure PressureWire is fully inserted into PressureWire transmitter. Note: When the slider is pushed forward, the wire is automatically zeroed. Do not turn off the slider while PressureWire Aeris is in the body; if this is done, it will then have to be removed from the body, placed in saline and zeroed again (turn off and then on again). If the wire needs to be re-zeroed during the procedure, it must first be taken out of the body and inserted in the packaging coil so that the pressure sensor is covered with saline. Place the packaging coil flat. If the pressure is still not zero after this – zero pressure channel P3 on the hemodynamic system with the wire still in the packaging coil. If the receiver is activated and PressureWire Aeris is not turned on during 60 seconds, the receiver will resume normal standby operation again.

FFR Procedure – Calibrate PressureWire Lay PressureWire packaging coil flat and flush with saline. Click Connect.

FFR Procedure – Turn on the PressureWire transmitter Turn on the PressureWire transmitter by sliding the button forward. The Pd “Searching” is lit. Wait until transmitter and ILUMIEN are connected. NOTE: After calibrating PressureWire, give an extra puff with saline to see that you get a pressure change on the Pd curve. In this way, you confirm that you have connected the correct PressureWire to the correct ILUMIEN system.

FFR Procedure – Equalize Position the AO transducer at heart level (i.e., 5 cm below sternum or at the mid axillary line). Advance PresssureWire until sensor is just outside catheter tip. At this point the pressures should be equal.

FFR Procedure – Equalize If the pressures are not equal: Adjust height of AO transducer Flush catheter with saline Make sure there is no introducer needle in the hemostatic valve and that the valve is properly closed If there still is a pressure difference of less than +/- 5 (e.g., Pd/Pa 0.95 to 1.05), you can electronically remove the difference by clicking EQ

FFR Procedure – Start a Recording Advance the sensor as distal as possible in the vessel, or at least distal to the most distal narrowing that you want to evaluate. Start/inject the hyperemic agent and press Record.

FFR Procedure – Recording New Image, New Wave form AO higher than PW When the recording is started, you will see: Yellow horizontal line and the value of Pd/Pa Time recorded Icon to put markers (Mark) in the recorded sequence Stop button

FFR Procedure – View Recorded Sequence When the Stop button is activated, the recorded sequence will be displayed. The vertical cursor (green) is placed at the lowest recorded FFR value, together with the time when the lowest FFR was measured. You will also see how long the recorded sequence was. You have the possibility to: Zoom in/Zoom out Edit the evaluated vessel Edit the procedure Edit what hyperemic drug was used Automatically jump to previous lowest FFR value or to the next lowest FFR value

Rx Only Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. ILUMIEN, PressureWire, RadiAnalyzer, Dragonfly, C7-XR, GOLDEN IMAGE, the color Gold, LIGHTLAB, Wi-Box, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. ©2011 St. Jude Medical, Inc. All rights reserved IPN 1681-11