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26. To Rotate the diffuser, select the Rotation mode with the
Mode Select Button on the Foot Pedal (circled below),
and use the grey pedals to rotate the diffuser clockwise or
counter clockwise. The rotational arrows will illuminate
to indicate to user is in Rotation mode.
Lights indicate
rotation mode
27. To adjust the Axial position of the diffuser, select the
Translate mode on the Foot Pedal with the Mode Select
Button, and use the grey pedals to move the diffuser
distally or proximally. The axial arrows will illuminate to
indicate to user that Foot Pedal is in Translate mode.
Lights indicate
translate mode
28. Repeat Step 24 to verify position.
Note: During ablation, the inflated balloon remains stationary.
Note: During ablation, the Focal catheter diffuser remains
stationary for the duration of the selected dosimetry time.
The diffuser for all other catheter configurations travels
proximally at the selected dosimetry rate.
29. To perform ablation, press and hold the Blue Ablation
Foot Pedal. Cryogen is continuously delivered from the
diffuser for the entire ablation duration. During ablation,
the Control Panel will indicate that Ablating is in process,
and a beep sounds every second.
Caution: To stop the flow of cryogen during ablation prior to
the full ablation duration, release the Ablation pedal.
30. Cryogen flow will automatically stop after the user
selected duration has elapsed.
LBL-1045 Rev
12
31. An extended audible sound signals when ablation is
complete. Release the ablation pedal.
Note: The balloon inflates to approximately 4.5 psig (0.3
ATM). The balloon pressure cannot be altered by the
user.
Exchange Cartridge
32. Additional ablations can be performed with the current
Cartridge until the Exchange Cartridge prompt appears.
33. To exchange the Cartridge, slowly rotate the Controller
Cap counterclockwise approximately 90 degrees, then
allow a few seconds in that position followed by
completely unscrewing the cartridge slowly. Any
remaining nitrous will escape. Dispose of the used
Cartridge.
34. Install a new Cartridge by following Steps 7 to 8.
35. Perform additional ablation by following Steps 20 to 31.
Catheter Withdrawal
36. Prior to withdrawal, return the diffuser to the distal most
position and straighten the distal end of the endoscope.
Any excess bend on the endoscope will increase the
resistance during withdrawal of the Catheter.
37. Follow one of the two techniques to withdraw the
Catheter into the endoscope:
a)
Press and hold the Deflate button on the Foot Pedal
and withdraw the Catheter into the endoscope.
Release the button when the Catheter has been fully
withdrawn into the endoscope. Or,
b) Attach a 30mL syringe to the luer-activated v alv e
that is attached to the Catheter. Draw a vacuum t o
fully deflate the balloon. Maintain the vacuum and
slowly retract the Catheter into the endoscope.
Caution: If there is excessive resistance, remove the
endoscope and Catheter as a unit.
38. With the balloon outside the scope, press
Control Panel to detach the Catheter from the Controller.
Dispose of the Catheter according to standard hospital
guidelines for the disposal of medical waste.
39. When the procedure has been completed, remove the
Cartridge from the Controller and dispose of the
Cartridge.
40. Clean/disinfect Controller and clean Foot Pedal and store
as desired.
Troubleshooting
If a fault condition occurs, the LCD touch screen on the
Controller will display an Error Description with
recommended Corrective Action. If the Corrective Action
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