Preparation; Zeroing The Pressure Guidewire; Diagnostic Procedure; Intervention - Boston Scientific Comet Mode D'emploi

Preparation

1. Ensure the receiving system and FFR Link are connected, powered on, and
functioning properly.
Note: Refer to the receiving system User Guide throughout this procedure for
instructions on using the system.
2. Remove the sterile pouch from the carton. Verify the device is suitable for
use by checking the expiration date and ensuring the packaging and sterile
barrier are intact. Do not use if the sterile package is damaged or the product
is expired.
3. Use standard sterile technique to open the pouch and remove the tray lid.
Leave the pressure guidewire in the carrier tube. Ensure that the pressure
guidewire is securely connected to the optical cable.
4. Flush the carrier tube with heparinized saline by injecting into the hub end of
the carrier tube to hydrate the hydrophilic segment of the pressure guidewire.

Zeroing the Pressure Guidewire

5. Place the carrier tube on a flat surface.
6. Insert the optical cable connector into the Pd IN port on the FFR Link. Upon
recognizing the pressure guidewire, the FFR Link will perform an automatic zeroing.
Note: If the pressure guidewire is not recognized, attempt to disconnect and
reconnect the pressure guidewire to the FFR Link. If the system still will not
recognize the pressure guidewire, use a new pressure guidewire.

Diagnostic Procedure

7. Carefully remove the pressure guidewire from the carrier tube and inspect it
for damage.
Note: Do not use a damaged device. If the pressure guidewire cannot be
removed easily, repeat the injection of heparinized saline into the hub end of
the carrier tube and attempt to remove the pressure guidewire again.
8. If desired, the tip may be carefully shaped according to standard tip shaping
practices. Do not use a shaping instrument with a sharp edge and take care
not to damage the sensor during shaping.
9. Open the hemostatic valve and the flush line of the coronary manifold. Insert
a guidewire insertion tool through the valve and into the guide catheter.
10. Carefully insert the distal tip of the pressure guidewire through the insertion
tool and into the guide catheter.
11. Remove the insertion tool from the hemostatic valve and continue to advance
the guidewire. Tighten the hemostatic valve knurled knob so that the valve
seals around the guidewire, but does not inhibit intentional wire movement.
Note: The brachial/femoral markers may be used to facilitate advancement.
12. Position the pressure guidewire sensor, which is 3 cm from the tip of the
pressure guidewire, just distal to the tip of the guide catheter.
13. Flush the guide catheter with heparinized saline until all contrast is removed.
14. Ensure the aortic pressure transducer is at the height of the heart.
15. Allow the waveforms and trendlines to stabilize.
16. Use the system to equalize the pressure guidewire and aortic pressure
transducer to 1.00 +/- 0.01. During equalization, do not disconnect the optical
cable from the pressure guidewire or FFR Link.
Note: If the equalization is not successful, repeat the equalization procedure.
Refer to receiving system Directions for Use for instructions.
17. Advance the pressure guidewire to the desired location for measurement.
Note: If a different tip shape or pressure guidewire is required, carefully
withdraw and remove the pressure guidewire while observing pressure
guidewire movement under fluoroscopy.
18. If using FFR modality, use standard technique to induce maximum
hyperemic condition.
19. Begin recording pressure using the receiving system. If using FFR modality,
record pressure until a steady state of maximum hyperemic condition is
reached, or until the hyperemic effect starts to decrease.
20. Use the receiving system to stop recording, and review the data.
21. After every recording, withdraw the pressure guidewire to the equalization
position, so that the sensor is just distal to the guide catheter tip, and recheck
the pressure equalization. If necessary, repeat steps 16-20.
22. If additional measurements are to be taken from other locations, reposition
the pressure guidewire and repeat steps 16-21.
23. If intervention is required, refer to the Intervention instructions below.

Intervention

The Comet™ Pressure Guidewire or a different guidewire may be used for delivery
of the interventional device. If using the pressure guidewire for the intervention,
perform the following steps:
24. Disconnect the pressure guidewire from the optical cable handle.
25. Remove the torque device.
26. Clean the proximal end of the pressure guidewire with a saline-soaked gauze.
27. Carefully advance the interventional device over the pressure guidewire
according to manufacturer's instructions.
28. Perform the intervention using standard practice according to
manufacturer's instructions.
29. If additional measurements are needed following intervention, carefully
clean the proximal end of the pressure guidewire and reconnect the pressure
guidewire to the optical cable handle.
Note: Exercise care to not excessively twist nut on optical cable handle.
30. Verify proper connection on the receiving system.
31. Return to step 16 above.

How to Finish the Procedure

32. When the procedure is complete, remove and discard the pressure guidewire
and optical cable.
33. Use the receiving system to review pressure data.
34. Shutdown the FFR Link and receiving system when finished.
5
Black (K) ∆E ≤5.0