23
ENGLISH
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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
2
canister low or empty
A screen will display “Replace CO
2
” with an image of the back of the
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
2
event . Pressing the foot switch
will not turn off the audible alarm .
1 . Replace the CO
2
canister to stop the audible tone .
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 .
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.
Model 10 RFC USERS ONL
Y
Содержание NovaSure Advanced
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