Hologic NovaSure Advanced Instructions For Use And Controller Operator'S Manual Download Page 19

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The acceptable limits on Pc = 180 W ± 10% . If Pc is not within
specification, a system fault will occur . The actual value of Rs is
for reference only .

NOTE:

If a system fault occurs during the POST, toggle off the

power at the power input module and repeat the POST . If a
system fault occurs a second time, remove the RF controller
from service and contact Hologic customer service .

CAUTION:

Do not attempt to repair the controller if problems

are suspected . Follow the troubleshooting guide in this
manual . If problems persist, call Hologic Technical Support
for instructions .

Sterile NovaSure disposable device: No maintenance is necessary .
Single-patient use only . Do not reuse or re-sterilize the NovaSure
disposable device .

NovaSure RF Controller LED Descriptions

The following is a description of the alert LEDs on the
NovaSure RF controller .

CAVITY ASSESSMENT LED:

illuminates in four modes:

1 . Flashes red in conjunction with an audible tone at a rate of
once per second for the first 10 seconds when the system is
purging air out of the disposable device . After 10 seconds, the LED
and audible tone will cease, although CO

will continue to flow out

of the vacuum feedback line .
2 .  Flashes green in conjunction with an audible tone at a rate of
once per second when the system is performing a cavity integrity
assessment .
3 .  Steady green light appears when the cavity integrity
assessment 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 .
4 .  Steady red lights and an audible tone at a rate of four times
per second occur when the cavity integrity assessment has failed .
The CIA test may be tried again .

ENABLE LED:

illuminates amber when the user presses the

ENABLE button . Acts as a safety so that the NovaSure disposable
device will not accidentally activate when the foot switch is
touched . The ENABLE LED will not illuminate when the ARRAY
POSITION LED is on .

RF ON LED:

illuminates blue when the ablation is proceeding (the foot

switch has been depressed to activate the NovaSure RF controller with
the NovaSure disposable device array in place in the uterus) .

PROCEDURE COMPLETE LED:

illuminates when the tissue impedance

reaches 50 ohms and the ablation procedure runs a minimum of
30 seconds .

ARRAY POSITION LED:

illuminates red when one pole of the electrode

array may be in contact with another . This LED should be illuminated
when the array is not fully deployed . The ENABLE LED cannot be toggled

on, nor can power be delivered to the array when the ARRAY POSITION
LED is illuminated .

VACUUM LED:

illuminates in two conditions:

1 . Flashes red accompanied by an audible tone while the system is

stabilizing the vacuum level for up to 10 seconds before energy
delivery commences (only for Model 09 controllers with a vacuum
pre-check function) .

2 . Illuminates red when the vacuum relief valve is stuck in the closed

position, when a blockage is detected in the disposable device or the
connection tubing or when the system has a leak . Such a situation
might be created by:

•

an over-dilated cervix with poor contact between the cervical collar
and the external os;

•

a poor attachment of the desiccant tube to the suction tubing;

•

an obstruction in the disposable device tubing; or

•

an obstruction in the disposable device .

SYSTEM FAULT LED:

illuminates red if the system faults or if there is a

self-diagnostic check failure with the system clock or power delivery . If
this event occurs, terminate the procedure immediately and contact an
authorized Hologic service representative for instructions .

Troubleshooting Most Common Alarms

CAVITY ASSESSMENT LED illuminated red

If the CAVITY ASSESSMENT LED is steady red, the cavity integrity
assessment has failed . 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 .
The CIA test may be tried again .

If a perforation is suspected, the procedure should be terminated
immediately .

If the cavity integrity assessment fails, press the foot switch to stop the
sound . The cause of the cavity integrity assessment failure is the inability
to pressurize the cavity . It may be caused by:
1 . Device leak: ensure that the suction line desiccant filter has been

installed . Check all tubing connections to ensure that they are tightly
connected .

2 . Leak at the external os of the cervix: Look for visible bubbles or a

“hissing” sound at the external os of the cervix .

Use the tab on the cervical collar to advance the cervical collar
towards the external os of the cervix to ensure there is a tight seal .
Test again . If the test fails again, use a second tenaculum to grasp
the cervix around the sheath of the NovaSure disposable device . Test
again .

3 . Uterine perforation:

If a uterine perforation is suspected, the

procedure should be terminated immediately .

NOTE:

leakage may occur at the external cervical os due to the

presence of an over-dilated cervix . Visible bubbles or the “hissing”

Model 08-09 RFC USERS ONL