Additional Troubleshooting; Replacement Instructions - Hologic Nova Sure 08 RF Mode D'emploi Et Manuel

ENGLISH

Additional Troubleshooting

Suspected uterine perforation
Prior to Application of Energy:
1. Terminate the procedure
2. Assure patient stability
3. Consider work-up for
perforation
4. Reschedule procedure,
if appropriate
Array does not fully deploy and lock in uterus
1. Partially retract array into sheath (hold the front handle
stationary and pull the rear handle back and away from the
patient);
2. Reposition the disposable device in the cavity;
3. Redeploy the array in cavity;
4. If the disposable device does not lock, remove it from the
uterus;
5. Inspect the disposable device for damage;
6. Attempt to open the disposable device and lock it outside the
patient;
7. If damaged, the replace disposable device;
8. If the disposable device is not damaged, reinsert it into the
patient's uterine cavity and attempt deployment; and
9. If unable to deploy the disposable device to a minimum 2.5 cm
cornu-to-cornu distance, terminate the procedure.
10. Consider uterine perforation as a possible cause for not
deploying.
Difficulty closing and removing the disposable device
post-ablation
Confirm that the lock release button is depressed:
• If so, gradually withdraw the disposable device from the
patient.
• If not, press the lock release button and reattempt to close the
disposable device. If it is still difficult to close, gradually withdraw
the disposable device from the patient.
ENABLE LED will not illuminate (Model 08-09 RFCs only)
Be sure:
1. The ENABLE button is firmly depressed;
2. The NovaSure RF controller is plugged in;
3. The toggle switch at the back of the controller is on; and
4. The ARRAY POSITION LED is not illuminated.
During or after Application of
Energy:
1. Terminate the procedure
2. Assure patient stability
3. Rule out visceral injury
4. Reschedule procedure,
if appropriate
PROCEDURE COMPLETE LED not illuminated (Model 08-09 RFCs)
or "Procedure Complete" Screen does not appear (Model 10
RFC) at the end of a procedure
1. If power has not been applied for at least 30 seconds, the LED will
not illuminate (Model 08-09 RFCs) or the "Procedure Complete"
Screen will not appear (Model 10 RFC). Remove the NovaSure
disposable device from the uterus after fully retracting the disposable
device array into the sheath:
A. Release the disposable device lock release button;
B. Hold the disposable device front handle steady; and
C. Pull the disposable device rear handle backward.
2. Inspect the disposable device for any damage. Fully deploy the
electrode array outside the patient, demonstrating that the ARRAY
POSITION LED does not illuminate (Model 08-09 RFCs) or that the
message does not display (Model 10 RFCs).
3. If the disposable device is not damaged and the ARRAY POSITION
LED extinguishes (Model 08-09 RFCs) or the message screen
does not appear (Model 10 RFC), reinsert, redeploy and reattempt
treatment.
4. If the problem persists, replace the disposable device with a new
disposable device.
5. Reattempt the procedure. If the problem persists, terminate the
procedure.
RF ON LED will not illuminate (Model 08-09 RFCs) or the "RF
ON" screen will not appear (Model 10 RFC)
1. If the NovaSure RF controller is plugged in, switched on, the ENABLE
button has been pressed and no power is delivered from the
controller when the foot switch is depressed, check the foot switch
connection. Also make sure the CAVITY ASSESSMENT has passed.
2. If the problem persists, terminate the procedure.
UP/DOWN values will not appear when pressing the appropriate
buttons
Make sure that the disposable device is connected to the controller.
The values will not appear unless the disposable device is properly
connected to the controller.

Replacement Instructions

The NovaSure RF controller uses a pair of fuses that are located on
a fuse carrier in the power input module. Type T5AH, 250 V fuses are
used. The module can be accessed by using a slotted screwdriver to
pop open the fuse carrier door. If required, the fuse carrier may then be
removed and the fuses changed. Assembly is the reverse of these steps.
Any potentially defective NovaSure product must be returned to Hologic
for evaluation. Follow the instructions at the end of this manual in the
Service Returns section, for obtaining a returned materials authorization
number (RMA #). Do not discard the NovaSure disposable device.
24