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2 .8 Take a sound measurement of the uterus to measure the length
from fundus to external cervical os . The efficacy of the NovaSure
system has not been fully evaluated in patients with a uterine
sound measurement greater than 10 cm .
2 .9 Determine the length of the cervical canal and dilate the canal
for device insertion .
NOTE: The diameter of the NovaSure disposable device is a
nominal 6 mm .
2 .10 Using the uterine sound and cervical canal measurements, consult
the cavity length table (below) to obtain the appropriate cavity
length settings . On the upper end of the table, dimensions have
been adjusted to reflect the disposable device electrode length .
Correct determination of the cavity length is important for safe and
effective treatment . Overestimating the cavity length may result in
thermal injury to the endocervical canal .
WARNING: Use caution not to perforate the uterine wall when
sounding, dilating or inserting the disposable device .
TABLE 8. CAVITY LENGTH
Uterine Sound (cm)
Cervix
Length
(cm)
10
9 .5
9
2
6 .5* 6 .5* 6 .5*
2 .5
6 .5* 6 .5*
6 .5
3
6 .5*
6 .5
6
3 .5
6 .5
6
5 .5
4
6
5 .5
5
4 .5
5 .5
5
4 .5
5
5
4 .5
4
5 .5
4 .5
4
6
4
* The value of 6 .5 is not intended to reflect the numerical difference between the sound length
and the length of the cervical canal .
The value 6 .5 was entered because it represents the maximum length that the NovaSure
array can be extended .
CONTRAINDICATION: Do not treat a patient with a uterine cavity
length that is less than 4 cm, as cervical canal damage may occur .
NOTE: Patients with a uterine cavity length greater than 6 .0 cm had
observed success rates that were lower than overall study success
rates .
2 .11 Open the sterile NovaSure disposable device package . Place the
disposable device with the connecting cord into the sterile field
while being careful to keep the non-sterile suction line desiccant
box out of the sterile field .
8 .5
8
7 .5
7
6 .5
6 .5
6
5 .5
5
4 .5
6
5 .5
5
4 .5
4
5 .5
5
4 .5
4
5
4 .5
4
4 .5
4
4
WARNING: Do not use the sterile single-patient use disposable
device if the packaging appears to be damaged or there is evidence
of tampering .
2 .12 Open the non-sterile suction line desiccant box and pouch .
Remove the red caps .
CAUTION: The suction line desiccant is non-sterile and the
packaging should not be placed in the sterile field .
CAUTION: If the suction line desiccant is pink, then replace it prior
to initiating the ablation procedure .
6
2 .13 Connect the desiccant to the barbs on the suction tubing of
4
disposable device . Ensure the barbs are fully inserted into the
tubing on the desiccant .
2 .14 CAUTION: Disposable device must be external to (outside of)
the patient before performing step 2 .15 .
2 .15 Connect the disposable device cord to the appropriate port on the
front panel of the controller .
Disposable Device
Port
WARNING: Plugging the NovaSure disposable device into the
NovaSure RF controller starts CO
of 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
11
ENGLISH
flow to purge any air out
2
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