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2.5 Prepare and drape patient similar to prep for D&C.
2.6 Insert a speculum into the vagina.
2.7 Grasp the cervix with a tenaculum.
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.
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
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.
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
6
to initiating the ablation procedure.
4
2.13 Connect the desiccant to the barbs on the suction tubing of
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
11
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