Hologic Nova Sure 08 RF Mode D'emploi Et Manuel page 20

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.
VACUUM LED illuminated
The VACUUM LED illuminates when the vacuum level is outside its
specified range. This can occur as a result of one or more of the
following:
• an over-dilated cervix;
• poor contact between the cervical collar and the external cervical os;
• the vacuum relief valve is in the closed position;
• an obstruction in the disposable device filter(s) (two) or desiccant; or
• an obstruction within the disposable device.
To eliminate this condition, perform the following:
• Gently press a 2–3.5 mm uterine dilator or sound inside the vacuum
relief valve.
• Check the cervical collar position, and reposition it if necessary. 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. Verify that air is
not being drawn through the cervix by a loose fit between the cervical
collar and the entrance to the cervical canal. If air is being drawn in
through the cervical canal, try to reposition the cervical collar and
disposable device shaft to prevent air ingress.
• Ensure the suction canister on the disposable device is vertical and the
device tubing is not draped over the patient's leg.
• Check all tubing connections to ensure that they are tightly connected.
Check the push-on tubing connectors at the desiccant tube. Replace
the dessicant if it is pink. Ensure that the filter located near the
disposable connection on the vacuum feedback line is tightened.
• Reattempt ablation.
If the VACUUM LED illuminates again:
• Disconnect the disposable device from the RF controller.
• Remove the disposable device from the patient, then;
• Exchange the disposable device with a new disposable device.
• Reattempt the ablation with the new device.
If a vacuum alarm occurs with the new device, 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.
CO canister low or empty
2
The NovaSure RF controller will generate an audible tone at a rate
of four times per second during this alarm condition. LEDs that
were illuminated prior to the alarm will remain in the same state
during the low CO event. Pressing the foot switch will not turn off
2
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 LED illuminated
1. Gently move the proximal end of the disposable device and
observe if the ARRAY POSITION LED extinguishes. If it does not,
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 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 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 LED is still illuminated, 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 LED
extinguishes.
6. Attempt reinsertion, redeployment and reseating of the disposable
device using the seating procedure described in section 2.0.
7. If the ARRAY POSITION LED remains illuminated, replace with a new
disposable device.
8. If the ARRAY POSITION LED remains illuminated with a new
disposable device, terminate the procedure.
Please turn to page 24 for the remainder of
the Instructions for Use.
19
ENGLISH