Hologic NovaSure Advanced, Instructions For Use And Controller Operator'S Manual

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Operating the Model 08-09 RF Controllers
A . Automatic mode
To operate the system in automatic mode, press the ENABLE
button prior to beginning the Cavity Integrity Assessment (CIA) .
Proceed to step 2 .36, but do not follow step 2 .37 if operating the
system in automatic mode .
B . Manual mode
To operate the system in the manual mode, do not press the
ENABLE 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 .
The CAVITY ASSESSMENT LED flashes green in conjunction with
an audible tone at a rate of once per second when the system
is performing a CIA . The duration of the test will range between
approximately 7 and 30 seconds . A steady green LED appears
when the CIA has passed and the system can deliver RF energy .
Power cannot be applied to the disposable device until the CAVITY
ASSESSMENT LED is a steady green light .
If the cavity integrity assessment fails, then the CAVITY
ASSESSMENT LED on the NovaSure RF controller will flash red,
and a rapid audible tone will sound at a rate of four times per
second .
If the cavity integrity assessment fails, press the foot switch to stop the
sound . Next:
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 by pressing the foot switch .
NOTE: CO
2
leakage may occur at the external cervical os due to the
presence of an over-dilated cervix . Visible bubbles or the “hissing”
sound of escaping gas may accompany CO
2
leakage under either of
these conditions .
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 successful completion of the
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 some Model 09 RF controllers, a vacuum pre-check
occurs automatically prior to initiation of the ablation cycle . The
VACUUM LED will flash and an audible tone will be heard for up to
10 seconds during the vacuum pre-check .
During the ablation cycle, a blue RF ON LED will illuminate . At the
completion of the ablation cycle, the RF power delivery (RF ON
LED), as well as suction, will switch off automatically . The physician
can stop the progress of the procedure at any time by depressing
the foot switch .
NOTE: RF power delivery can be stopped at any time by pressing
the foot switch
Model 08-09 RFC USERS ONL
Y
MANUAL MODE