ENGLISH
Operating the Model 10 RF Controller
A. Automatic mode
To operate the Model 10 RFC in Automatic Mode, press the
"Switch Mode" button when it appears at the bottom of the
screen. Proceed to step 2.36, but do not follow step 2.37 if
operating the system in automatic mode.
B. Manual mode
NOTE: Manual Mode is the default system operation.
To operate the system in manual mode, do not press the "Switch
Mode" button prior to beginning the cavity integrity assessment
(CIA). Follow steps 2.36 and 2.37.
2.36 Begin the CIA procedure by stepping on the foot switch once.
"Cavity Assessment in Progress" will display on the screen while
five dots light off and on sequentially. The duration of the test
will range between approximately 7 and 30 seconds. A "Cavity
Assessment Complete" screen displays when the CIA has passed
and the system can deliver RF energy. Power cannot be applied to
the disposable device until the CIA Complete screen displays.
If the cavity integrity assessment fails, a screen will display
"Cavity Assessment Failure" with troubleshooting steps.
A. If a perforation is suspected, the procedure should be
terminated immediately.
B. If the CIA test fails again, check for leaks in the system, and
between the cervix and cervical collar. Be sure to check all tubing
connections, and ensure that a suction line desiccant has been
installed. If the leak appears to be at the cervix and cannot be
resolved by using the cervical collar, use another tenaculum
to grasp the cervix around the sheath. Repeat the CIA test by
pressing the foot switch.
NOTE: CO
leakage may occur at the external cervical os due to the
2
presence of an over-dilated cervix. Visible bubbles or the "hissing"
sound of escaping gas may accompany CO
these conditions.
leakage under either of
2
20
C.
If the cavity integrity assessment fails after reasonable attempts to
implement the troubleshooting procedures (step 2.36), abort the
procedure.
NOTE: Removing the disposable device from the uterine cavity after
completing a cavity integrity assessment will require an additional
CIA test to be performed upon disposable device re-insertion
(whether or not the CIA previously passed) prior to initiating an
ablation.
2.37 Manual Mode Only
When operating the system in manual mode, the ablation cycle
will not start automatically after the successfully completion of the
cavity integrity assessment (CIA). Once a successful CIA has been
completed, press the ENABLE button and depress the foot switch a
second time to initiate the ablation cycle.
NOTE: In all Model 10 RF controllers, a vacuum pre-check occurs
automatically prior to initiation of the ablation cycle. A "Vacuum
Check in Progress" screen will appear and an audible tone will be
heard for up to 10 seconds during the vacuum pre-check.
During the ablation cycle, an "RF ON" screen with a timer will
appear to track the duration of the ablation.
NOTE: RF power delivery can be stopped at any time by pressing
the foot switch.
2.38 After automatic termination of the ablation cycle (approximately 90
seconds), fully retract the cervical collar to its proximal position by
using the tab on the cervical collar.
CAUTION: The cervical collar must be fully retracted to its proximal
position in order to minimize the potential for damage to the sheath
when closing the array.
Cervical
Collar