Pentax C2 CryoBalloon Mode D'emploi page 5


The C2 CryoBalloon™ Controller should not be used in
the presence of flammable anesthetics.

In the event that the C2 CryoBalloon Controller is
dropped, discard and replace it.
Foot Pedal Preparation
1. Open the Foot Pedal package and remove the Power
Cable and Foot Pedal.
2. Plug the Power Cable into the Foot Pedal power supply.
3. Plug the Power Cable plug into the mains power source.
4. Position the Foot Pedal at the desired location.
Controller Preparation
5. Open the Controller package and remove the Controller
and Controller Cap. Open the Cartridge package and
remove a Cartridge.
6. Plug the Interconnect Cable of the Foot Pedal into the
Controller to power it on. Confirm the cable is securely
attached. (Figure 4)
Figure 4 – Interconnect Cable to Controller
Controller
Cable Receptacle
Note: Upon initial start-up, language selection is required.
7. Insert the round end of the Cartridge into the Controller
Cap (press firmly).
Caution: Use only C2 CryoBalloon™ Cartridges.
8. Insert the Controller Cap and Cartridge into the Controller
and rotate the Controller Cap clockwise until it stops. This
action breaks the seal on the Cartridge.
Catheter Insertion
9. Open the package and remove the Catheter.
Caution: Do not remove the Catheter Connector Cap
(proximal) or Protective Sheath (distal) until instructed.
10. Remove the biopsy valve cap and insert the Catheter
Balloon Probe constrained within the Protective Sheath
into the biopsy valve of the endoscope (3.7 mm ID
minimum; 105 cm length maximum).
Caution: Do not pre-inflate or pre-test the balloon. Do not
attempt to refold the balloon into the Protective Sheath. If
the balloon is not constrained within the Protective Sheath
prior to use, discard and replace the Catheter.
11. Grasp the Catheter close to the endoscope and advance
the Catheter through the Protective Sheath and through
the biopsy valve (Figure 5).
LBL-1045 Rev 12
Interconnect
Cable
PENTAX Medical
Figure 5 – Insert Catheter into the Biopsy Valve
Protective
Sheath
12. Continue advancing the Catheter until the balloon exits
the endoscope.
Caution: Visualize the Catheter tip as it exits the endoscope.
13. Withdraw the Protective Sheath from of the biopsy valve
and slide proximally onto the Catheter shaft (Figure 6).
Figure 6 – Slide the Protective Sheath Proximally
Catheter Positioning
14. Position the distal end of the endoscope approximately 2
to 3 cm proximal to the ablation site.
15. Advance the Catheter out of the endoscope until the black
Catheter shaft (proximal to the balloon) is visible. Retract
the Catheter into the endoscope until there is slight
resistance (balloon contacting endoscope).
16. Remove and discard the Catheter Connector Cap.
17. Insert the Catheter Connector into the Controller. An
audible "click" will be heard. Lightly tug on the
Connector and Controller to confirm a secure connection.
18. After the Catheter has been connected, press
verify that a Catheter has been connected.
Catheter
to
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