Pentax C2 CryoBalloon Mode D'emploi page 6

Ablation Dosimetry Selection
19. Using the Controller Control Panel, select the desired
ablation dosimetry. Refer to specific dosimetry
information in the Catheter Instructions For Use (IFU).
The System is ready for ablation after the ablation
dosimetry has been selected.
Balloon Pre-Inflation and Ablation
20. When the Cartridge is at operational pressure, the orange
Standby Icon will change to a blue Ready Icon ,
and an audible beep will sound.
21. Hold the Controller upright with the Controller Cap
pointing vertically (towards the ceiling). Ablation will be
disabled if the Controller orientation is incorrect.
22. To pre-inflate the balloon, perform a "puff" by depressing
and quickly releasing the Blue Ablation Foot Pedal
(circled below). Each puff releases a small amount of
cryogen.
Note: This will deliver a small amount of cryogen that inflates
the balloon so that it is in contact with the tissue.
Caution: Do not occlude the exhaust ports during ablation.
23. Visualize the ablation site through the balloon. Retract or
advance the Catheter for optimal positioning.
Warning: If using the Pear balloon, do not ablate tissue adjacent
to the larger balloon diameter that is not clearly visualized.
Note: If using the Pear balloon in a treatment zone lumen that
has different diameters, such as in the gastroesophageal
LBL-1045 Rev 12
Point towards
the ceiling
Grip here
PENTAX Medical
junction or the proximal margin of a hiatal hernia, position the
proximal (smaller) balloon diameter in the smaller proximal
lumen and the distal (larger) balloon diameter in the larger
distal lumen (Figure 7).
Figure 7 – Pear Balloon Positioning
Smaller
Diameter
Balloon
Larger
Diameter
Balloon
24. To visualize the target tissue area, perform another puff.
While the balloon is inflated, the cryogen from each puff
will momentarily freeze the targeted tissue area, turning it
white.
Note: Markings on the nitrous oxide delivery Hypotube aide
visualization of the rotation and translation of the
diffuser. The nitrous oxide exit hole on the diffuser are
aligned to the circle markings and dash markings are on the
opposite side.
25. To reposition the balloon proximally or distally press the
Deflate button on the Foot Pedal (circled below), or
deflation and inflation of the balloon can be achieved by
attaching a 30 mL syringe to the Luer Activated Valve on
the Catheter Connector. Reposition the balloon and repeat
step 22 through step 24 to confirm the position.
Cryogen
Spray Area
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