Indications; Contraindications; Warnings - Hologic Nova Sure 08 RF Mode D'emploi Et Manuel

NovaSure Suction Line Desiccant
Description
The NovaSure suction line desiccant
is a non-sterile, single-patient use
component that the user attaches
in-line with the suction tubing, prior
to connecting the disposable device
to the NovaSure RF controller. The
desiccant absorbs the moisture
removed from the uterine cavity via
the suction tubing during the ablation
procedure.
NovaSure Foot Switch
Description
The NovaSure foot switch is a
pneumatic switch that connects to the
NovaSure RF controller front panel. It
is used to activate the NovaSure RF
controller and does not contain any
electrical components.
NovaSure CO Canister
2
Description
The NovaSure CO canister is a 16-
2
gram CO (USP) canister. It is attached
2
to the regulator located on the back
panel of the NovaSure RF controller
prior to applying line voltage to
the NovaSure RF controller. The
CO is used by the cavity integrity
2
assessment system to pressurize the
uterine cavity.
NovaSure AC Power Cord
Description
The NovaSure AC power cord,
a medical grade cord, connects
the NovaSure RF controller to
the appropriate line voltage. The
receptacle for the power cord, the
power input module, is located on
the back panel of the NovaSure RF
controller.

INDICATIONS

The NovaSure system is intended to ablate the endometrial lining of the
uterus in pre-menopausal women with menorrhagia (excessive bleeding)
due to benign causes for whom childbearing is complete.

CONTRAINDICATIONS

The NovaSure impedance controlled endometrial ablation system is
contraindicated for use in:
• a patient who is pregnant or who wants to become pregnant in the
future. Pregnancies following ablation can be dangerous for both
mother and fetus.
• a patient with known or suspected endometrial carcinoma (uterine
cancer) or pre-malignant conditions of the endometrium, such as
unresolved adenomatous hyperplasia.
• a patient with any anatomic condition (e.g., history of previous
classical cesarean section or transmural myomectomy) or pathologic
condition (e.g., long-term medical therapy) that could lead to
weakening of the myometrium.
• a patient with active genital or urinary tract infection at the time of
the procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis or
cystitis).
• a patient with an intrauterine device (IUD) currently in place.
Presence of an IUD in the uterine cavity can interfere with a NovaSure
procedure.
• a patient with a uterine cavity length less than 4 cm. The minimum
length of the electrode array is 4 cm. Treatment of a uterine cavity with
a length less than 4 cm will result in thermal injury to the endocervical
canal.
• a patient with a uterine cavity width less than 2.5 cm, as determined
by the WIDTH dial of the disposable device following device
deployment.
• a patient with active pelvic inflammatory disease.

WARNINGS

FAILURE TO FOLLOW ANY INSTRUCTIONS OR FAILURE TO HEED
ANY WARNINGS OR CAUTIONS COULD RESULT IN SERIOUS PATIENT
INJURY.
THE NOVASURE DISPOSABLE DEVICE MUST BE USED ONLY IN
CONJUNCTION WITH THE NOVASURE RF CONTROLLER.
THE NOVASURE PROCEDURE IS INTENDED TO BE PERFORMED ONLY
ONCE DURING A SINGLE OPERATIVE VISIT. THERMAL INJURY TO THE
BOWEL MAY OCCUR WHEN MULTIPLE NOVASURE THERAPY CYCLES
ARE PERFORMED DURING THE SAME OPERATIVE VISIT.
Uterine Perforation
• Use caution not to perforate the uterine wall when sounding, dilating
or inserting the disposable device.
• If the disposable device is difficult to insert into the cervical canal,
use clinical judgment to determine whether or not further dilation is
required.
• The NovaSure system performs a cavity integrity assessment (CIA)
to evaluate the integrity of the uterine cavity and sounds an alarm
warning of a possible perforation prior to treatment (Step 2.36).
(Although designed to detect a perforation of the uterine wall, it is
an indicator only and it might not detect all perforations under all
possible circumstances. Clinical judgment must always be used.)
• If a uterine perforation is suspected, the procedure should be
terminated immediately.
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ENGLISH