NOTE: When following the troubleshooting steps on the Model 10
RFC, press the "?" button on the screen and use the scroll buttons
on the right for more information. To get back to the main screen
from the additional troubleshooting tips, press the "X" in the top
right corner of the screen.
If the vacuum alarm occurs with the new device, abort the procedure.
NOTE: Removing the disposable device from the uterine cavity after
completing a cavity integrity assesment 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.
CO
canister low or empty
2
A screen will display "Replace CO
controller. An audible tone will be generated at a rate of 1 time per
second. Alarm messages that were present prior to the alarm will remain
in the same state during the replace CO
will not turn off the audible alarm.
1. Replace the CO
canister to stop the audible tone.
2
NOTE: It is not necessary to remove the disposable device from the
patient prior to replacing the canister.
2. Continue with the procedure.
ARRAY POSITION Alarm
The Array Position message displays when the array is not open fully.
The controller cannot perform ablation when Array Position message
displays. If the ARRAY POSITION alarm occurs, a screen will display
"Check Array" with an abridged version of the following troubleshooting
tips:
1. Gently move the proximal end of the disposable device and observe
if the Array Position message no longer displays. If it still displays,
proceed with the following:
2. Attempt gentle reseating of the NovaSure disposable device:
A.
Partially retract the array into the sheath by releasing the
disposable device handle lock release button;
B.
Pull the disposable device back slightly from the fundus;
C.
Slowly redeploy the disposable device array while gently
rocking the disposable device back and forth and locking the
disposable device handles; and
D.
Reseat the disposable device against the fundus using the
seating procedure described in steps 2.26 through 2.33.
3. If the uterus is retroverted, take special care to avoid perforation.
Apply gentle caudad traction to the cervix with the tenaculum, and
elevate the disposable device handle upward toward the ceiling
(in-line with the axis of the uterus) while performing the seating
procedure.
" with an image of the back of the
2
event. Pressing the foot switch
2
4. If the Array Position message still displays, fully retract the
disposable device array and remove the disposable device
from the patient.
5. Deploy the disposable device outside the patient's body;
ensure the electrode array is undamaged and that the Array
Position message no longer displays.
6. Attempt reinsertion, redeployment and reseating of the
disposable device using the seating procedure described in
section 2.0.
7. If the Array Position message still displays, replace with a new
disposable device.
8. If the Array Position message displays with a new disposable
device, terminate the procedure.
NOTE: When following the troubleshooting steps on the Model
10 RFC, press the "?" button on the screen and use the scroll
buttons on the right for more information. To get back to the
main screen from the additional troubleshooting tips, press
the "X" in the top right corner of the screen.
Please turn to next page 24 for the
remainder of the Instructions for Use.
23
ENGLISH