Hologic NovaSure Advanced, Instructions For Use And Controller Operator'S Manual

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• If the cavity integrity assessment fails after reasonable attempts
to implement the troubleshooting procedures (step 2 .36), abort
the procedure .
• For patients in whom the procedure was aborted due to a suspected
uterine wall perforation, a work-up for perforation should be
considered prior to discharge .
General
• Endometrial ablation using the NovaSure system is not a sterilization
procedure . Therefore, the patient should be advised of appropriate
birth control methods .
• Endometrial ablation does not eliminate the potential for endometrial
hyperplasia or adenocarcinoma of the endometrium and may mask the
physician’s ability to detect or make a diagnosis of such pathology .
• Endometrial ablation is intended for use only in women who do
not desire to bear children because the likelihood of pregnancy is
significantly decreased following the procedure . Pregnancy following
ablation may be dangerous for both mother and fetus .
• Patients who undergo endometrial ablation procedures who have
previously undergone tubal ligation are at increased risk of developing
post ablation tubal sterilization syndrome which can require
hysterectomy . This can occur as late as 10 years post procedure .
• A health hazard may exist in the case where the NovaSure procedure
is performed in the presence of a thermally and electrically conductive
Essure
®
micro-insert that is improperly positioned (e .g ., perforating the
fallopian tube or the myometrium) . If this occurs, heat can be drawn
away from the intended treatment area toward other tissue and/or
organs in contact with the conductive object, which may be sufficient
to cause localized burns . As a result, correct placement of the Essure
micro-insert must be confirmed, e .g ., by obtaining the report of the
Essure Confirmation Test (ECT), prior to performing the NovaSure
procedure . If the report and/or ECT films are unavailable, the ECT
should be repeated to confirm correct placement of the Essure micro-
inserts prior to performing the NovaSure procedure .
Technical
• Do not use the sterile, single-patient use disposable device if the
packaging appears to be damaged or there is evidence of tampering .
• The disposable device is for single-patient use only . Do not reuse or
re-sterilize the disposable device .
• If any hysteroscopy procedure is performed with hypotonic solution
immediately prior to NovaSure treatment, then the uterine cavity must
be flushed with normal saline prior to treatment with the NovaSure
system . The presence of hypotonic fluid may reduce the efficiency of
the NovaSure system .
• Plugging the disposable device into the controller starts CO
2
flow to
purge any air out of the disposable device and tubing . This purging
operation takes approximately 10 seconds and
must be performed
with the disposable device external to the patient to eliminate
the risk of air or gas embolism
. The NovaSure RF controller CAVITY
ASSESSMENT LED flashes red (Model 08-09 RFCs) or a purging device
screen appears (Model 10 RFC) and an audible pulsed tone sounds
throughout the purge procedure . When the tone and the LED/screen
message stops it is safe to insert the disposable device .
• For patients with cardiac pacemakers or other active implants, a
possible hazard exists due to interference with the action of the
pacemaker that may occur and may damage the pacemaker . Consult
the pacemaker manufacturer for further information when use of the
NovaSure system is planned in patients with cardiac pacemakers .
• Care should be taken to ensure the patient does not contact metal
parts which are earthed or which have an appreciable capacitance to
earth, such as direct contact with the metal on tables .
•
Danger: explosion hazard .
Do not use in the presence of a flammable
anesthetic mixture . Do not use in the presence of flammable gases or
liquids .
• Failure of the NovaSure RF controller could result in an unintended
increase in output power .
PRECAUTIONS
• It has been reported in the literature that patients with a severely
anteverted, retroflexed or laterally displaced uterus are at greater risk
of uterine wall perforation during any intrauterine manipulation .
• A false passage can occur during any procedure in which the uterus
is instrumented, especially in cases of severe anteverted retroflexed
or a laterally displaced uterus . Use caution to ensure that the device is
properly positioned in the uterine cavity .
• The NovaSure system consists of the following components:
- single-patient use NovaSure disposable device with connecting cord
- NovaSure RF controller
- NovaSure CO
2
canister
- NovaSure desiccant
- NovaSure foot switch
- power cord
To ensure proper operation, never use other components with the
NovaSure system . Inspect the components regularly for damage,
and do not use them if damage is apparent . The use of any cables or
accessories other than those specified in these instructions may result
in increased emissions or decreased immunity of the RF controller .
• The RF controller must be installed and put into service according
to the guidance provided in these instructions to ensure its
electromagnetic compatibility . Refer to the electromagnetic emissions
and immunity tables in the Specifications section .
• The RF controller should not be used adjacent to or stacked with other
equipment . If adjacent or stacked use is necessary, the RF controller
should be observed to verify normal operation in the configuration in
which it will be used .
• Portable and mobile RF communications equipment can affect the
RF controller . Refer to the electromagnetic immunity tables in the
Specifications section for recommended separation distances .
• Patients who have undergone endometrial ablation and are later
placed on hormone replacement therapy should have a progestin