Hologic Nova Sure 08 RF Mode D'emploi Et Manuel page 13

ENGLISH
WARNING: Plugging the NovaSure disposable device into the
NovaSure RF controller starts CO
the disposable device and tubing. The purging operation takes
approximately 10 seconds and must be performed with the
disposable device external to the patient. The NovaSure RF
controller CAVITY ASSESSMENT LED flashes red (Model 08-09
RFCs) or a purging device message displays (Model 10 RFC) and an
audible pulsed tone sounds throughout the purge procedure. When
the tone and the LED/screen message stop, it is safe to insert the
NovaSure disposable device.
CAUTION: CO
continuously flows from the time that the disposable
2
device is plugged into the controller until the CIA portion of the
procedure is complete. To minimize the duration of CO
and potential risk of embolism, perform the seating procedure
immediately after inserting the disposable device and proceed
directly from the seating procedure to the CIA.
WARNING: Use caution not to perforate the uterine wall when
sounding, dilating or inserting the disposable device.
2.16 Deploy the disposable device outside of the patient and ensure the
controller ARRAY POSITION LED is extinguished (Model 08-09 RFCs)
or the screen message does not display (Model 10 RFC) when the
array is opened. If the LED is not extinguished (Model 08-09 RFCs)
or the screen message is still displayed (Model 10 RFC), close
and open the disposable device again. If this does not resolve the
problem, replace the disposable device.
2.17 Be certain the WIDTH dial reads greater than or equal to 4.0 cm.
WIDTH dial
NOTE: If the WIDTH dial reads less than 4.0 cm, close the disposable
device and repeat step 2.16 above. If the WIDTH dial still reads
less than 4.0 cm, open a new disposable device and return the old
disposable device to Hologic Technical Support.
2.18 Unlock the disposable device by pressing the lock release button.
Close the disposable device by holding the front handle stationary
and gently pulling the rear handle backwards until the closed array
indicator, located at the hinge of the front and rear handles, reads,
"ARRAY CLOSED". This indicates that the array has been retracted
into the sheath and the disposable device is in the closed position.
flow to purge any air out of
2
flow
2
ARRAY
CLOSED
indicator
2.19 Make sure the array is completely enclosed by the external sheath.
2.20 Check that the WIDTH dial reads approximately 0.5 cm.
2.21 Using the uterine sound measurement and cervical canal
measurements, consult the cavity length table (above) to obtain the
appropriate cavity length settings as described in step 2.10 above.
CONTRAINDICATION: Do not treat a patient with a uterine cavity
length that is less than 4 cm, as cervical canal damage may occur.
2.22 Using the cavity length table in section 2.10, select the value
obtained for length into the NovaSure RF controller input screen by
depressing the UP/DOWN arrows.
2.23 Adjust and lock the cavity length setting feature on the disposable
device to the value obtained above. (See step 2.21.) Ensure that the
cervical collar is fully retracted to its proximal position.
2.24 Confirm that the cervix is dilated to a minimum 6 mm (the nominal
diameter of the NovaSure disposable device).
2.25 Maintain a slight traction on the tenaculum to minimize the angle of
the uterus.
2.26 Angle the disposable device in-line with the axis of the uterus as
the disposable device is inserted transcervically into the uterine
cavity. By holding the front handle, advance the disposable device
until the distal end of the sheath touches the fundus.
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Lock release
button