Hologic NovaSure Istruzioni per l'uso

MAN-08932-4270 Rev.002

07/2022

Hologic BV • Da Vincilaan 5 • 1930 Zaventem, Belgium

Tel: +32 2 711 46 80 • Fax: +32 2 725 20 87

Instructions for Use and Controller Operator's Manual

Gebruiksaanwijzing en handleiding voor de regelaar

Mode d'emploi et manuel de l'opérateur du contrôleur

Gebrauchsanweisung und Betriebshandbuch für den Controller

Istruzioni per l'uso e manuale operativo del controller

Krachtens de federale wetgeving (VS) mag dit toestel slechts worden verkocht door of in opdracht

van een arts met de juiste training voor de bediening van dit apparaat.

En vertu de la loi fédérale des États-Unis, ce dispositif ne peut être vendu que par un médecin

ou sur ordonnance médicale.

Laut US-Bundesgesetz darf dieses Produkt nur von einem Arzt oder im Auftrag eines Arztes mit

entsprechender Schulung erworben werden.

La legge federale statunitense limita la vendita di questo dispositivo ai medici dotati di adeguata

preparazione o su prescrizione degli stessi.

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CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO

SALE BY OR ON THE ORDER OF A PHYSICIAN TRAINED IN THE

USE OF THE DEVICE.

Read all instructions, cautions and warnings prior to use. Failure

to follow any instructions or to heed any warnings or precautions

could result in serious patient injury.

NOTE: The manual that accompanied the disposable device may

contain a more recent revision of the NovaSuresystem instructions

than the manual provided with the controller.

The NovaSuredisposable device is not to be used with other

controllers and/or RF generators, and the NovaSureRFcontroller is

not to be used with other disposable devices.

The NovaSure disposable device does not contain latex.

Physician Checklist

The physician must:

• have sufﬁcient experience in performing procedures within the uterine

cavity, such as IUD insertion or dilation and curettage (D&C) and with

adequate training, knowledge and familiarity using the NovaSure

system;

• review and be familiar with the instructions and complete either

NovaSure training or be trained by a qualiﬁed physician;

• be aware of the appropriate sequence of actions detailed in the

Instructions for Use and Troubleshooting sections of this manual to

abort, resolve and/or continue the treatment in the event the system

detects a loss of CO2 during the cavity integrity assessment (CIA),

which indicates a possible uterine perforation.

Adjunct personnel must be familiar with these instructions and other

training materials prior to using the NovaSure system.

System Description

The NovaSure impedance controlled endometrial ablation system

consists of the NovaSure disposable device with connecting cord,

NovaSure RF controller (controller), NovaSure CO2 canister, desiccant,

foot switch and power cord, which are designed to be used together as

a system.

NovaSure Disposable Device with Connecting Cord,

Including Suction Line Desiccant

NovaSure Disposable Device Description

Table of Contents

Physician Checklist ..................................1

System Description ..................................1

Indications .........................................3

Patient Target Group .................................3

Intended Clinical Beneﬁts to Patients ....................3

Intended User .......................................3

Contraindications ...................................3

Warnings ..........................................4

Precautions ........................................5

NovaSure 3-Year Clinical Data .........................6

Adverse Events ....................................6

Anticipated Post-Procedural Complications ...............6

Other Adverse Events ...............................6

Clinical Study .....................................7

Patient Selection ................................... 9

Patient Counseling ................................10

Pretreatment Preparation of Patient .................... 10

NovaSure Impedance Controlled Endometrial Ablation System

Instructions For Use ................................10

Operating the Model 10 RF Controller ..................15

Periodic Maintenance and Service ....................16

NovaSure Model 10 RF Controller Screen Icons ...........17

Troubleshooting Most Common Alarms .................17

Replacement Instructions ............................19

Technical Speciﬁcations .............................19

NovaSure disposable device .........................19

NovaSure RF controller .............................20

Environmental Conditions ..........................20

Important Performance Characteristics ................21

Electromagnetic Safety Guidance .....................21

Cleaning and Sanitizing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Parts List .......................................23

Disposal ..........................................23

Warranty .........................................23

Technical Support and Product Return Information. . . . . . . . 24

Symbol Glossary ...................................24

NovaSure®

Instructions for Use and Controller

Operator’s Manual

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The NovaSure disposable device consists of a single-patient use,

conformable bipolar electrode array mounted on an expandable frame

that can create a conﬂuent lesion on the entire interior surface area

of the uterine cavity. The disposable device is inserted transcervically

into the uterine cavity, and the sheath is retracted to allow the bipolar

electrode array to be deployed and conform to the uterine cavity.

The bipolar electrode array is formed from a metalized, porous fabric

through which steam and moisture are continuously suctioned from

the desiccated tissue. The disposable device works in conjunction

with a dedicated NovaSure RF controller to perform customized, global

endometrial ablation in an average of approximately 90seconds without

the need for concomitant hysteroscopic visualization or endometrial

pretreatment. The speciﬁc conﬁguration of the bipolar electrode array

and the predetermined power of the controller create a controlled depth

of ablation in uteri sounding less than or equal to 10cm and having a

minimum cornu-to-cornu distance of 2.5cm.

During the ablation process, the ﬂow of radio frequency (RF) energy

vaporizes and/or coagulates the endometrium regardless of its thickness

and desiccates and coagulates the underlying, superﬁcial myometrium.

The controller automatically calculates the optimal power level (W)

required for the treatment of the uterine cavity, based on uterine size.

As tissue destruction reaches an optimal depth, increasing tissue

impedance causes the controller to automatically terminate power

delivery, thereby providing a self-regulating process. Blood, saline and

other liquid present in the uterine cavity at the time of the procedure,

as well as vapor liberated from the desiccated tissue, are evacuated by

continuous, automatic suctioning.

The disposable device is connected to the controller via a cord

containing the RF cable, suction tubing used for pressure monitoring

during the cavity integrity assessment cycle and for suction during the

ablation cycle, and vacuum feedback tubing used for carbon dioxide

delivery during the cavity integrity assessment cycle and vacuum

monitoring during the ablation cycle. The disposable device has been

sterillized with ethylene oxide (EO).

NovaSure RF Controller Description

The NovaSure RF controller is a constant power output generator with a

nominal maximum power delivery capability of 180 watts. The controller

automatically calculates the power output based on the uterine cavity

length (sound measurement minus the length of the endocervical canal)

and width measurements that the user key-enters into the controller.

Monitoring tissue impedance during the ablation process automatically

controls the depth of endo-myometrial ablation. The NovaSure procedure

self-terminates once endometrial vaporization and superﬁcial myometrial

desiccation have reached approximately 50ohms of impedance at the

tissue-electrode interface, or when the treatment timer reaches two

minutes. Integral to the controller is the cavity integrity assessment

system (CIA) which is designed to determine whether there is a defect

or perforation in the wall of the uterus. After the disposable device is

placed into the uterine cavity, CO2 is delivered through the central lumen

of the disposable device into the cavity, via the vacuum feedback tubing,

at a safe ﬂow rate and pressure. If the CO2 pressure in the cavity is

maintained for a short period of time, indicating that the uterine cavity is

intact, then the CIA will allow the NovaSure RF controller to be enabled

and proceed with the treatment phase. A vacuum pump contained

within the NovaSure RF controller creates and maintains a vacuum in

the uterine cavity throughout the endometrial ablation procedure. Once

the vacuum is stabilized, the vacuum level is monitored throughout the

remainder of the ablation process.

NovaSure Model 10

RF Controller

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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 CO2 Canister

Description

The NovaSure CO2 canister is a 16-

gram CO2 (USP) canister. It is attached

to the regulator located on the back

panel of the NovaSureRFcontroller

prior to applying line voltage to

the NovaSureRFcontroller. The

CO2 is used by the cavity integrity

assessment system to pressurize the

uterine cavity.

The CO2 canister PN: 815012 is at

least 99% CO2.

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.

Patient Target Group

The NovaSure system is intended for use on pre-menopausal women

with menorrhagia (excessive bleeding) due to benign causes for whom

childbearing is complete.

Intended Clinical Beneﬁts to Patients

To reduce or eliminate bleeding in pre-menopausal women with Heavy

Menstrual Bleeding due to benign causes for whom childbearing is

complete.

Intended User

The NovaSure System will be used under control and guidance of an OB/

GYN physician or GYN physician or surgeon. The physician will primarily

operate the NovaSure device and may provide instructions to the

assistant on the operation of the RF Controller and activate the controller

using the foot switch. The RF Controller will be operated by a non-sterile

assistant.

The physician must:

• Have sufﬁcient experience in performing procedures within the uterine

cavity, such as IUD insertion or dilation and curettage (D&C) and with

adequate training, knowledge and familiarity using the NovaSure

system.

• Review and be familiar with the instructions and complete either

NovaSure training or be trained by a qualiﬁed physician.

Adjunct personnel must be familiar with the Instructions for Use and

other training materials prior to using the NovaSure system.

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.

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• 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.

•The markings added to the distal end of the Novasure device

are for reference only. The Novasure Disposable Device is not

intended to be used as a sounding measuring tool.

• 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 procedures

is performed in the presence of a thermally and electrically conductive

metal micro-insert that is improperly positioned conﬁrmed 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 CO2 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. A purging device screen appears on

the 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

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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 CO2 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

included in their medication regimen in order to avoid the increased

risk of endometrial adenocarcinoma associated with unopposed

estrogen replacement therapy.

• The safety and effectiveness of the NovaSure system has not been

fully evaluated in patients:

- with a uterine sound measurement greater than 10cm;

- with submucosal ﬁbroids that distort the uterine cavity;

- with bicornuate, septate or sub-septateuteri;

- with medical (e.g., GnRH agonist) or surgical pretreatment;

- who have undergone a previous endometrial ablation including the

NovaSure endometrial ablation procedure; or,

- who are post-menopausal.

• Do not attempt to repair the controller if problems are suspected.

Call Hologic Technical Support or a Hologic sales representative for

instructions.

• Cables to the disposable device should be positioned such that contact

with patient or other leads is avoided.

• The user should inspect the disposable device for damage prior to use.

• The suction line desiccant is non-sterile, and the packaging should not

be placed in the sterile ﬁeld.

• If an Array Position message is displayed on the Model 10 screen,

see the Troubleshooting section under “ARRAY POSITION ALARM”.

• Do not use the NovaSure suction line desiccant if desiccant material is

pink in color.

• The disposable device must be external to (outside of) the patient

before connecting the cord to the appropriate port on the front panel of

the controller (step 2.15).

• The carbon dioxide canister contains gas under high pressure. In the

event of a breached CO2 canister or line, allow the canister to exhaust

completely, and allow the canister and/or lines to equilibrate to room

temperature prior to handling.

• CO2 continuously ﬂows from the time that the disposable device is

plugged into the controller until the CIA portion of the procedure is

complete. To minimize the duration of CO2 ﬂow 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.

• Electrically conductive objects (e.g., monitoring electrodes from other

devices) that are in direct contact with the electrode array of the

disposable device or in close proximity to the electrode array may

draw current away from the array. This may result in localized burns

to the patient or physician or in distortion of the electrical ﬁeld of the

array, which would change the therapeutic effect (under-treatment or

over-treatment). It may also result in distortion of the current in the

conductive object, e.g., monitors may display false readings.

• Grounding reliability is only achieved when equipment is connected to

a receptacle marked “hospital grade”.

• To avoid risk to patient and operators, do not use this equipment in

the presence of intentional magnetic sources, intentional ultrasound

sources, or intentional heat sources.

• The cervical collar must be fully retracted to its proximal position in

order to minimize the potential for damage to the sheath when closing

the array.

• The NovaSure device is contraindicated for use in pregnant women

or women that want to become pregnant in the future. Pregnancies

following ablation can be dangerous for both mother and fetus. Sound

medical judgment should be used.

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NovaSure 3-Year Clinical Data

Adverse Events

The NovaSure system was evaluated in a randomized, prospective,

multi-center clinical study of 265patients with abnormal uterine

bleeding comparing the NovaSure system to a control arm of wire loop

resection of the endometrium followed by rollerball ablation.

Table 1A. Intra-Operative Adverse Events

Adverse Event

NovaSure

n=175 (%)

Loop Resection

Plus Rollerball

n=90 (%)

Bradycardia 1 (0.6%) 0 (0.0%)

Uterine perforation 0 (0.0% 3 (3.3%)

Cervical tear 0 (0.0% 2 (2.2%)

Cervical stenosis 0 (0.0% 1 (1.1%)

TOTAL 1 (0.6%) 6 (6.7%)

Table 1B. Post-Operative Adverse Events < 24 Hours

Adverse Event

NovaSure

n=175 (%)

Loop Resection

Plus Rollerball

n=90 (%)

Pelvic pain/cramping 6 (3.4%) 4 (4.4%)

Nausea and/or vomiting 3 (1.7%) 1 (1.1%)

TOTAL 9 (5.1%)* 5 (5.6%)**

* Nine events reported in 6 (3.4%) patients

** Five events reported in 4 (4.4%) patients

Table 1C. Post-Operative Adverse Events > 24 Hours – 2 Weeks

Adverse Event

NovaSure

n=175 (%)

Loop Resection

Plus Rollerball

n=90 (%)

Hematometra 1 (0.6%) 0 (0.0%

Urinary tract infection 1 (0.6%) 1 (1.1%)

Vaginal infection 1 (0.6%) 0 (0.0%

Endometritis 0 (0.0% 2 (2.2%)

Pelvic inﬂammatory disease 0 (0.0% 1 (1.1%)

Hemorrhage 0 (0.0% 1 (1.1%)

Pelvic pain/cramping 1 (0.6%) 1 (1.1%)

Nausea and/or vomiting 1 (0.6%) 1 (1.1%)

TOTAL 5 (2.9%)* 7 (7.8%)**

* Five events reported in 4 (2.3%) patients

** Seven events reported in 6 (6.7%) patients

Table 1D. Post-Operative Adverse Events > 2 Weeks – 1 Year

Adverse Event

NovaSure

n=175(%)

Loop Resection

Plus Rollerball

n=90 (%)

Hysterectomy 3 (1.7%) 2 (2.2%)

Hematometra 1 (0.6%) 2 (2.2%)

Urinary tract infection 2 (1.1%) 2 (2.2%)

Vaginal infection 5 (2.9%) 2 (2.2%)

Endometritis 2 (1.1%) 1 (1.1%)

Pelvic inﬂammatory disease 2 (1.1%) 0 (0.0%

Hemorrhage 1 (0.6%) 0 (0.0%

Pelvic pain/cramping 5 (2.9%) 6 (6.7%)

TOTAL 21 (12.0%)* 15 (16.17%)**

* 21 events in 19 (10.9%) patients

** 15 events in 15 (16.7%) patients

Anticipated Post-Procedural Complications

For any endometrial ablation procedure, commonly reported post-

operative events include the following:

• Cramping/pelvic pain was reported for 3.4% of the NovaSure patients

and 4.4% of the wire resection loop plus rollerball-treated patients

within 24hours of the procedure. Postoperative cramping can range

from mild to severe. This cramping will typically last a few hours and

rarely continues beyond the ﬁrst day following the procedure.

• Nausea and vomiting were reported for 1.7% of the NovaSure patients

and 1.1% of the wire loop resection plus rollerball patients within

24hours of the procedure. When present, nausea and vomiting

typically occur immediately following the procedure, are associated

with anesthesia and can be managed with medication.

• Vaginal discharge

• Vaginal bleeding/spotting

Other Adverse Events

As with all endometrial ablation procedures, serious injury or death can occur.

The following adverse events could occur or have been reported in

association with the use of the NovaSure system:

• post-ablation tubal sterilization syndrome

• pregnancy-related complications (NOTE: PREGNANCY FOLLOWING

ENDOMETRIAL ABLATION IS VERY DANGEROUS FOR BOTH THE

MOTHER AND THE FETUS.)

• thermal injury to adjacent tissue

• perforation of the uterine wall

• difﬁculty with defecation or micturition

• uterine necrosis

• air or gas embolism

• infection or sepsis

• complications leading to serious injury or death

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Clinical Study

Purpose: Safety and effectiveness of the use of the NovaSure system

was compared to wire loop resection of the endometrium followed by

rollerball ablation in premenopausal women suffering from menorrhagia

secondary to benign causes.

Pretreatment: Patients randomized into the NovaSure arm received

no endometrial pretreatment (e.g., hormone, D&C or patient timing).

Patients randomized into the control arm received wire loop resection as

an endometrial pretreatment.

Study endpoints: The primary effectiveness measure was a validated

menstrual diary scoring system developed by Higham (Higham JM,

O’Brien PMS, Shaw RW Br J Obstet Gynaecol 1990; 97:734-9).

Assessment of menstrual blood loss was performed using a pictorial

blood loss assessment chart (PBLAC). Patient success was deﬁned as

a reduction in menstrual ﬂow at 1 year post-procedure to a diary score

of <75. Study success was deﬁned as a statistical difference of less

than 20% in patient success rates between the NovaSure impedance

controlled endometrial ablation system and wire loop resection plus

rollerball ablation. Patients were contacted at two and three years and

asked a series of questions regarding their bleeding over the previous

12months. Each patient’s menstrual bleeding status was determined

at two and three years using the one-year PBLAC score and bleeding

pattern as a reference. Thus, it was possible to directly compare a

patient’s bleeding pattern or menstrual status at one year to the bleeding

pattern at two and three years.

Secondary endpoints included anesthesia regimen, length of procedure

and responses from a quality-of-life questionnaire. Safety evaluation was

based on the adverse events reported during the study.

Methods: A randomized (2:1), prospective clinical study was conducted

at 9clinical sites and included 265patients diagnosed with menorrhagia.

Menstrual diary scores were collected pre-operatively and monthly for

12months post-procedure. Patients were treated at any time in their

menstrual cycle. None of the patients received hormonal pretreatment

to thin the endometrial lining. Control patients received hysteroscopic

wire loop resection of the endometrium as a mechanical means of

endometrial pretreatment followed by rollerball ablation. Study subjects

were required to meet the following key patient selection criteria:

Inclusion criteria

• Refractory menorrhagia with no deﬁnable organic cause (dysfunctional

uterine bleeding)

• Ages 25 to 50years of age

• Uterine sound measurement of 6.0–10.0cm (external os to internal

fundus)

• Minimum PBLAC score of >150 for 3months prior to study enrollment;

or PBLAC score >150 for one month for women who:

- had at least 3 prior months (documented) failed medical therapy;

- had a contraindication to medical therapy; or

- refused medical therapy.

Exclusion criteria

• Presence of bacteremia, sepsis or other active systemic infection

• Active or recurrent chronic pelvic inﬂammatory disease

• Patient with documented coagulopathies or on anticoagulants

• Symptomatic endometriosis

• Prior uterine surgery (except low segment cesarean section)

that interrupts the integrity of the uterine wall e.g., transmural

myomectomy or classical cesarean section

• Prior endometrial ablation

• Patient on medications that could thin the myometrial muscle, such as

long-term steroid use

• Patient desire to have children or to preserve fertility

• Patient currently on hormonal birth control therapy or unwilling to use

a non-hormonal birth control post-ablation

• Abnormal/obstructed cavity as conﬁrmed by hysteroscopy, SIS or HSG.

Speciﬁcally:

- septate or bicornuate uterus or other congenital malformation of the

uterine cavity

- pedunculated, submucous leiomyomata or other leiomyomata which

distort the cavity; polyps (larger than 2cm) which are likely to be the

cause of the patient’s menorrhagia

- presence of an IUD

• Suspected or conﬁrmed uterine malignancy within the last ﬁve years

as conﬁrmed by histology

• Endometrial hyperplasia as conﬁrmed by histology

• Unaddressed cervical dysplasia

• Elevated FSH levels consistent with ovarian failure >40IU/ml

• Pregnancy

• Active sexually transmitted disease

Patient population: A total of 265patients were enrolled in this study.

Patients were between the ages of 25 to 50 with 46% under the age

of 40 and 54% 40years of age or older. There were no differences in

demographic or gynecological history parameters between the treatment

groups, between the age groupings or among the nine investigational sites.

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Table 2. Patient Accountability

Number of Patients NovaSure Wire Loop

Resection

Plus Rollerball

Entered into Study

(Intent-to-Treat population) 175 90

Aborted procedures*1-4 -2

Treated 171 88

Additional treatment* -4 -2

Hysterectomy*2-3 -2

Lost to follow-up* -5 -2

Hodgkin’s disease* -1 0

Pelvic Pain - administered

leuprolide*

-1 0

12-Month

follow-up data available 157 82

Additional treatment* -2 -1

Hysterectomy*2-3 -1

Lost to follow-up* -2 -5

Missed visit -1 -1

Declined to participate* -1 0

Pregnancy* -1 0

24-Month

follow-up data available 147 74

Additional treatment* 0 -4

Hysterectomy*2-5 -1

Lost to follow-up* -4 -2

36-Month follow-up 138 67

Subject lost to follow-up at

24 mos., returned at 36 mos.

+1 +1

36-Month follow-up data

available 139 68

* Discontinued patients

1 Four NovaSure did not meet protocol Inclusion Criteria; Two Rollerball had uterine perforation

2 For hysterectomy, see Table 7

Results

Primary effectiveness endpoint: bleeding score

Patient success at 12-months post-procedure is deﬁned as a reduction

in diary score from >150 pre-operatively to <75 post-procedure.

Amenorrhea is deﬁned as a score of 0. Success at 24 and 36 months,

based on telephone questionnaires, is deﬁned as elimination of bleeding

or reduction to light or normal ﬂow. Data presented in Table 3 (below)

represent the clinical results based on the total number of 265 patients

randomized (Intent-to-Treat group (ITT)) for the study. The worst-case

scenario is presented whereby each of the discontinued patients

(described in Table 2 for patient accountability) is counted as a “failure”

for calculating the values listed in the table.

Table 3. Effectiveness: Success Rates–Intent-To-Treat Patients

NovaSure

(n=175)

Wire Loop Resection

Plus Rollerball

(n=90)

Months post ablation 12* 24** 36** 12* 24** 36**

Number of

successful patients 136 143 134 67 68 63

Study success rate 77.7% 81.7% 76.6% 74.4% 75.6% 70.0%

# of patients with

Amenorrhea 63 64 58 29 26 23

Amenorrhea rate 36.0% 36.6% 33.1% 32.2% 28.9% 25.6%

* Based on diary scores

** Based on telephone questionnaires

Secondary effectiveness endpoint: quality of life

Patient quality of life (QOL) was assessed by administering the quality of

life questionnaire (SF-12) and the menstrual impact questionnaire prior

to treatment and at 3, 6, 12, 24 and 36months post-procedure. Table4

shows the patient responses for both groups pre-operatively, where

appropriate, and at 12, 24 and 36months post-procedure.

Table 4. Effectiveness: Quality of Life (QOL)

NovaSure Wire Loop Resection Plus

Rollerball

Number of Patients Responding to Quality of Life Questionaire#

Pre-operatively 175 90

12 Months 154 82

24 Months 143 73

36 Months 139 67

Percent of Patients Satisiﬁed Or Very Satisiﬁed

12 Months 92.8% 93.9%

24 Months 93.9% 89.1%

36 Months 96.3% 89.7%

Percent of Patients Who Probably Or Deﬁnitely Would Recommend This

Procedure

12 Months 96.7% 95.9%

24 Months 96.6% 94.5%

36 Months 97.8% 92.6%

Percent of Patients with Dysemenorrhea

Pre-operatively 57.1% 55.6%

12 Months 20.8%& 34.2%*,&

24 Months 20.3%* 30.1%*

36 Months 17.3%* 28.4%*

Percent of Patients with PMS

Pre-operatively 65.1% 66.7%

12 Months 36.4%* 35.4%*

24 Months 44.0%* 46.6%*

36 Months 34.5%* 41.2%*

Percent of Patients Reporting Sometimes, Frequently Or Always Have

Difﬁculty Performing Work Or Other Activities Due to Menses

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Table 4. Effectiveness: Quality of Life (QOL)

NovaSure Wire Loop Resection Plus

Rollerball

Pre-operatively 66.3% 65.5%

12 Months 9.9%* 8.6%*

24 Months 14.5%* 15.0%*

36 Months 16.3%* 13.3%*

Percent of Patients Reporting Sometimes, Frequently Or Always Feel

Anxious Due to Menses

Pre-operatively 74.7% 68.9%

12 Months 23.6%* 18.5%*

24 Months 24.2%* 19.2%*

36 Months 18.7%* 19.1%*

Percent of Patients Reporting Sometimes, Frequently Or Always Miss

Social Activities Due to Menses

Pre-operatively 63.3% 62.2%

12 Months 8.5%* 8.6%*

24 Months 9.0%* 11.1%*

36 Months 8.1%* 10.8%*

# Not all patients completed questionnaire

* Statistically signiﬁcant difference from pre-operative response (Chi-Square; p<0.05)

& Statistically signiﬁcant difference between NovaSure and Rollerball Groups

(Chi-Square; p=0.02)

Safety endpoint

Adverse event information is described in the “Adverse Events” section of this manual.

Secondary endpoint: procedure time

Procedure time, a secondary endpoint, was determined for each patient

by recording the time of device insertion and the time of device removal.

The mean procedure time for the NovaSure patients was signiﬁcantly

less than the procedure time for the rollerball group, (4.2 ±3.5 minutes

and 24.2 ±11.4 minutes, respectively). Mean time for application of RF

energy was 84.0 ±25.0 seconds in a subset of monitored NovaSure

patients (Table5).

Table 5. Operative Procedure Time

Operative Parameters NovaSure

n=175

Wire Loop Resection

Plus Rollerball

n=90

Number of treated patients* 171 88

Procedure time minutes (± SD)

(Device insertion to device

removal)

4.2 ± 3.5** 24.2 ± 11.4**

Procedure time in seconds (±SD)

(Time of energy delivery)

84.0 ± 25.0 ND#

* See Table 2 for patient accountability

** Statistically signiﬁcant difference between treatment groups (Student’s t-test; p < 0.05)

# Not determined

Secondary endpoint: anesthesia regimen

Anesthesia was left to the discretion of each patient, clinical investigator

and attending anesthesiologist. For the NovaSure patients, 27.0%

(47/174) had the procedure performed under general anesthesia or

epidural and 73.0% (127/174) under local and/or IV sedation. One

patient did not have a reported anesthesia regimen in this group. In

the rollerball group, 82.2% (74/90) of the patients were treated under

general anesthesia or epidural and 17.8% (16/90) under local and/or IV

sedation (Table6).

Table 6. Anesthesia Regimen

NovaSure

n=175*

Wire Loop Resection

Plus Rollerball

n=90

General or epidural 27.0% 82.2%

Local and/or IV sedation 73.0% 17.8%

* One patient did not have a reported anesthesia regimen.

Clinical observations

Hysterectomy

Fifteen women had a hysterectomy within the three years following the

ablation procedure. Table7 lists the reasons for hysterectomy.

Table 7. Hysterectomy

Reason For Hysterectomy NovaSure

n=175

Wire Loop Resection

Plus Rollerball

n=90

Adenocarcinoma diagnosed at

time of ablation procedure 1 1

Fibroids 2 0

Pelvic abscess 1 1

Endometriosis 3 0

Adenomyosis 4 0

Hematometra 0 1

Menorrhagia 0 1

TOTAL 11 (6.3%) 4 (4.4%)

7Hysterectomies were in patients <40years (7 NovaSure) and 8hysterectomies were in patients >40years

(4NovaSure; 4 Rollerball).

Patient Selection

Menorrhagia can be caused by a variety of underlying problems,

including, but not limited to; endometrial cancer, myomas, polyps, drugs

and dysfunctional uterine bleeding (anovulatory bleeding). Patients

always should be screened and evaluated to determine the cause of

excessive uterine bleeding before any treatment option is initiated.

Consult medical literature relative to various endometrial ablation

10

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techniques, indications, contraindications, complications and hazards

prior to the performance of any endometrial ablation procedure.

Patient Counseling

As with any procedure, the physician needs to discuss risks, beneﬁts

and alternatives with the patient prior to performing endometrial

ablation. Patient’s expectations should be set in a way that the patient

understands that the aim of the treatment is the reduction in bleeding to

normal levels.

The disposable device 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. Patients of childbearing

capacity should be cautioned of potential complications, which may

ensue if they should become pregnant. This counseling should include

the need for post-procedure contraception where indicated. This

procedure is not a sterilization procedure and subsequent pregnancies

may be dangerous for the mother and fetus.

Vaginal discharge is typically experienced during the ﬁrst few weeks

following ablation and may last as long as a month. Generally,

the discharge is described as bloody during the ﬁrst few days;

serosanguineous by approximately one week; then profuse and watery

thereafter. Any unusual or foul-smelling discharge should be reported to

the physician immediately. Other common post-procedural complications

include cramping/pelvic pain, nausea and vomiting.

Uterine perforation should be considered in the differential diagnosis of

any post-operative patient complaining of acute abdominal pain, fever,

shortness of breath, dizziness, hypotension or any other symptom that

may be associated with uterine perforation with or without damage

to the adjacent organs of the abdominal cavity. Patients should be

counseled that any such symptoms should be immediately reported to

their physician.

Pretreatment Preparation of Patient

The NovaSure impedance controlled endometrial ablation system

successfully treats a uterine cavity over a range of endometrium

thickness. The lining of the uterus does not have to be thinned prior to

the procedure, and the procedure may be performed during either the

proliferative or the secretory phase of the cycle. Although the safety and

effectiveness of the NovaSure system has not been fully-evaluated in

patients with medical or surgical pretreatment, it has been evaluated in a

limited number of patients who had been pretreated with GnRH agonists

with no complications or adverse events.

Active bleeding was not found to be a limiting factor when using

the NovaSure system. It is recommended that a nonsteroidal anti-

inﬂammatory drug (NSAID) be given at least one hour prior to treatment

and continued postoperatively to reduce intraoperative and postoperative

uterine cramping.

NovaSure Impedance Controlled Endometrial Ablation System

Instructions For Use

Please read all instructions, cautions and warnings prior to use.

1.0 Set-up

NOVASURE POWER CORD NOVASURE SUCTION LINE DESICCANT

NOVASURE CO2 CANISTER NOVASURE FOOT SWITCH

NOVASURE DISPOSABLE DEVICE

WITH CONNECTING CORD,

INCLUDING SUCTION LINE

DESICCANT

NOVASURE

RF CONTROLLER

1.1 The following items are required when using the NovaSure system:

• one sterile, single-patient use NovaSure disposable device with

connecting cord

• one NovaSure RF controller

• one NovaSure foot switch

• one NovaSure AC power cord

• one NovaSure non-sterile suction line desiccant assembly

• one NovaSure CO2 canister.

NOTE: Please have available at least one extra disposable device,

desiccant assembly and CO2 canister.

1.2 Prepare the NovaSure RF controller. Place it on a small table to one

side of the patient within visual ﬁeld of the surgeon. Attach the AC

power cord to the controller and plug it into the AC outlet.

1.3 Screw the CO2 canister into the regulator on the back panel of the

controller until tightened.

Vacuum

Relief ValveCervical Collar

Bipolar

Electrode

Array

Front Handle

Sheath

Rear

Handle

Suction

Line

Lock Release

Button Cavity Length Setting

Vacuum

Feedback

Line Barb

WIDTH Dial

11

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1.0 Set-up

NOVASURE POWER CORD NOVASURE SUCTION LINE DESICCANT

NOVASURE CO2 CANISTER NOVASURE FOOT SWITCH

NOVASURE DISPOSABLE DEVICE

WITH CONNECTING CORD,

INCLUDING SUCTION LINE

DESICCANT

NOVASURE

RF CONTROLLER

1.1 The following items are required when using the NovaSure system:

• one sterile, single-patient use NovaSure disposable device with

connecting cord

• one NovaSure RF controller

• one NovaSure foot switch

• one NovaSure AC power cord

• one NovaSure non-sterile suction line desiccant assembly

• one NovaSure CO2 canister.

NOTE: Please have available at least one extra disposable device,

desiccant assembly and CO2 canister.

1.2 Prepare the NovaSure RF controller. Place it on a small table to one

side of the patient within visual ﬁeld of the surgeon. Attach the AC

power cord to the controller and plug it into the AC outlet.

1.3 Screw the CO2 canister into the regulator on the back panel of the

controller until tightened.

1.4 Fully rotate the CO2 regulator knob to the HI position (if

equipped).

NOTE: Newer model controllers are not equipped with a knob

on the regulator, thus allowing the CO2 ﬂow to be automatically

regulated. If your controller is not equipped with a regulator

knob, proceed to step1.5.

1.5 Press the toggle switch on the back panel of the controller into

the “on” position.

1.6 Connect the foot switch to the appropriate port on the front

panel of the controller.

NOTE: The ﬁrst time the Model 10 RFC is turned on, the “Select Your

Language” screen will display. The default setting is in English.

To select another language, press the button with the name

of that language. Save the selection by pressing the ﬂashing

green button.

The language selection will be retained. To change the language

selection after the initial setup, use the “Settings” screen. Press the

name of the language to change the language used on the screen

display. To save changes to the settings, press the ﬂashing green

button. To cancel a selection, press the Blue “X”.

2.0 Procedure

2.1 Prepare the patient for the anesthesia.

2.2 Place patient in dorsal lithotomy position.

2.3 Induce anesthesia according to standard practice.

2.4 Perform bimanual examination. Evaluate for severe anteversion or

retroversion.

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.

Port

Toggle

switch

CO2 canister

AC

power

cord

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 8.5 8 7.5 7 6.5 6

26.5* 6.5* 6.5* 6.5 6 5.5 5 4.5 4

2.5 6.5* 6.5* 6.5 6 5.5 5 4.5 4

36.5* 6.5 6 5.5 5 4.5 4

3.5 6.5 6 5.5 5 4.5 4

46 5.5 5 4.5 4

4.5 5.5 5 4.5 4

55 4.5 4

5.5 4.5 4

64

* 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.

WARNING: Do not use the sterile single-patient use disposable device if

the packaging appears to be damaged or there is evidence of tampering.

12

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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.

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.

WARNING: Plugging the NovaSure disposable device into the

NovaSureRFcontroller starts CO2 ﬂow to purge any air out 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. A purging device message

displays on the 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.

Disposable Device

Port

CAUTION: CO2 continuously ﬂows from the time that the disposable

device is plugged into the controller until the CIA portion of the

procedure is complete. To minimize the duration of CO2 ﬂow

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 screen message does not display on the Model 10 RFC when

the array is opened. If the screen message is still displayed on the

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.

ARRAY

CLOSED

indicator

Lock release

button

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.

13

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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.

WARNING: If the disposable device is difﬁcult to insert into the

cervical canal, use clinical judgment to determine whether or not

further dilation is required.

2.27 As reference, conﬁrm fundal positioning by looking at the distal

mark that more closely approximates the external cervical canal

opening (external OS).

2.27.1 At this point, the reading on the sheath markings should be

equivalent to the sounding length measured at the beginning

of the case.

WARNING: DO NOT ADVANCE THE DEVICE FURTHER INTO THE

CAVITY IF THE READING ON THE SHEATH MARKING DOES NOT

MATCH THE INITIAL SOUNDING LENGTH. USE CLINICAL

JUDGMENT TO DETERMINE IF THE DEVICE IS CORRECTLY GOING

THROUGH THE CERVICAL CANAL AND NOT THROUGH A FALSE

PASSAGE.

2.28 Withdraw the disposable device approximately 0.5 cm from the

fundus. Slowly squeeze the handles (DO NOT LOCK) up to the point

of increased resistance.

The WIDTH dial should read approximately 0.5 cm. At this point, the

external sheath has been retracted.

PRECAUTION: During retraction of the sheath, the sheath markings

no longer represent the total sounding length, instead reﬂect the

cervical length. This is a result of deploying the Bipolar Electrode

Array into the uterine cavity and the sheath retracting from its

fundal position.

2.28.1 Continue to slowly squeeze the disposable device handles

together while gently moving the disposable device ~0.5 cm to and

from the fundus and rotating the handle of the disposable device 45º

counterclockwise from the vertical plane and 45º clockwise from the

vertical plane until the handles lock. The WIDTH dial should read greater

than 2.5 cm.

0.5 cm

14

ENGLISH

NOTE: Once the disposable device handles are locked, the uterus

should move in conjunction with the disposable device.

2.29 Gently move the disposable device using anterior, posterior and

lateral movements.

2.30 To complete placement, slightly pull back the disposable device

until the WIDTH dial reading reduces by approximately 0.2–0.5cm.

2.31 Hold the tenaculum, advance the disposable device slowly and

gently to the fundus. The WIDTH dial should read greater than or

equal to the previous measurement.

2.32 Slide the cervical collar forward using gentle pressure on the tab on

the cervical collar, until the cervical collar forms a seal against the

external cervical os.

2.33 Read the cornu-to-cornu measurement (2.5cm minimum) on the

WIDTH dial indicator.

CONTRAINDICATION: Do not treat 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.

CAUTION: If the ARRAY POSITION notiﬁcation appears, see the

Troubleshooting section under “ARRAY POSITION Alarm.”

2.34 Select the value indicated on the WIDTH dial into the NovaSure RF

controller input screen by depressing the UP/DOWN arrows.

2.35 The system can be operated in either automatic mode or manual

mode. In automatic mode the ablation cycle will start automatically

upon successful completion of the cavity integrity assessment

(CIA). In manual mode the ablation cycle will not start automatically

following a successful CIA.

Gentle pressure

Slight pressure

15

ENGLISH

NOTE: Correct placement of the electrode array against the fundus is important to safe and effective treatment. If part of the electrode array

or the distal edge of the external sheath is seated in the endocervical canal during treatment, there is an increased risk of endocervical

thermal injury.

Fundus

Sheath edge resides in

lower uterine segment

Electrode Array

Endocervical

Canal

Sheath Edge

Sheath edge resides in

endocervical canal

Fundus

INCORRECT PLACEMENT CORRECT PLACEMENT

Sheath Edge

Endocervical

Canal

Electrode Array

Operating the Model 10 RF Controller

A. Automatic mode

To operate the Model 10 RFC in Automatic Mode, press the

“Switch Mode” button when it appears at the bottom of the

screen. Proceed to step 2.36, but do not follow step 2.37 if

operating the system in automatic mode.

B. Manual mode

NOTE: Manual Mode is the default system operation.

To operate the system in manual mode, do not press the “Switch Mode”

button prior to beginning the cavity integrity assessment (CIA). Follow

steps 2.36 and 2.37.

2.36 Begin the CIA procedure by stepping on the foot switch once.

“Cavity Assessment in Progress” will display on the screen while

ﬁve dots light off and on sequentially. The duration of the test

will range between approximately 7 and 30 seconds. A “Cavity

Assessment Complete” screen displays when the CIA has passed

and the system can deliver RF energy. Power cannot be applied to

the disposable device until the CIA Complete screen displays.

If the cavity integrity assessment fails, a screen will display “Cavity

Assessment Failure” with troubleshooting steps.

A. If a perforation is suspected, the procedure should be terminated

immediately.

B. If the CIA test fails again, check for leaks in the system, and

between the cervix and cervical collar. Be sure to check all tubing

connections, and ensure that a suction line desiccant has been

installed. If the leak appears to be at the cervix and cannot be

resolved by using the cervical collar, use another tenaculum to

grasp the cervix around the sheath. Repeat the CIA test by pressing

the foot switch.

NOTE: CO2 leakage may occur at the external cervical os due to the

presence of an over-dilated cervix. Visible bubbles or the “hissing”

sound of escaping gas may accompany CO2 leakage under either of

these conditions.

C. If the cavity integrity assessment fails after reasonable attempts to

implement the troubleshooting procedures (step 2.36), abort the

procedure.

NOTE: Removing the disposable device from the uterine cavity after

completing a cavity integrity assessment will require an additional

CIA test to be performed upon disposable device re-insertion

16

ENGLISH

(whether or not the CIA previously passed) prior to initiating an

ablation.

2.37 Manual Mode Only

When operating the system in manual mode, the ablation cycle

will not start automatically after the successfully completion of the

cavity integrity assessment (CIA). Once a successful CIA has been

completed, press the ENABLE button and depress the foot switch a

second time to initiate the ablation cycle.

NOTE: In all Model 10 RF controllers, a vacuum pre-check occurs

automatically prior to initiation of the ablation cycle. A “Vacuum

Check in Progress” screen will appear and an audible tone will be

heard for up to 10 seconds during the vacuum pre-check.

During the ablation cycle, an “RF ON” screen with a timer will

appear to track the duration of the ablation.

NOTE: RF power delivery can be stopped at any time by pressing

the foot switch.

2.38 After automatic termination of the ablation cycle (approximately 90

seconds), fully retract the cervical collar to its proximal position by

using the tab on the cervical collar.

CAUTION: The cervical collar must be fully retracted to its proximal

position in order to minimize the potential for damage to the sheath

when closing the array.

At the completion of the ablation cycle, a “Procedure Complete” screen

will appear with a summary of the procedure. The “Procedure Complete”

screen will capture the following information for each procedure:

• Cavity Length

• Cavity Width

• Power Level

Cervical

Collar

• RF Ablation Time

2.39 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.

NOTE: If it is difﬁcult to close and remove the disposable device,

see the Troubleshooting section, “Difﬁculty closing and removing

the disposable device post-ablation”.

CAUTION: To avoid damaging the device, employ gentle technique

when retracting the array.

2.40 Withdraw the disposable device from the patient.

2.41 TURN OFF THE NOVASURE RF CONTROLLER.

2.42 Perform postoperative patient care according to standard

procedures.

2.43 Discharge the patient from the hospital or ofﬁce as indicated by the

managing physician.

Periodic Maintenance and Service

The RF controller has been designed and tested to meet IEC 60601-1

and other safety standards. Maintenance is not required as the system

performs self-checks when power is turned on. To clean the controller

refer to the “Cleaning and Sanitizing” section.

The expected life of the RF Controller is ﬁve years or 2000 procedures

provided that damage from physical impact, such as dropping or rough

handling is avoided. If the controller is dropped or suffers severe

physical impact, discontinue use and contact Hologic technical support.

Refer to the “Technical Support and Product Return Information” section.

There is no service manual for the NovaSure RF Controller since there

are no ﬁeld serviceable components within the unit.

WARNING: No modiﬁcation of this equipment is allowed.

17

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RF power output test

The NovaSure RF controller Model 10 integrates automatic power output

testing in a power on self test (POST). During the POST the controller’s

power output (Pc) is delivered into a shunt resistor (Rs) located inside

the controller. Pc is targeted to be 180 watts and Rs is nominally 25

ohms. During the POST, no power is delivered to the disposable device

connector at the front of the controller.

The NovaSure RF controller Model 10 performs POST automatically

upon power up. To access POST information, go to Settings and scroll to

System Information. Press the “View Info.” button.

NOTE: If a system fault occurs during the POST, toggle off the power

at the power input module and repeat the POST. If a system fault

occurs a second time, remove the RF controller from service and

contact Hologic Technical Support.

CAUTION: Do not attempt to repair the controller if problems are

suspected. Follow the troubleshooting guide in this manual. If

problems persist, call Hologic Technical Support for instructions.

Sterile NovaSure disposable device: No maintenance is necessary.

Single-patient use only. Do not reuse or re-sterilize the NovaSure

disposable device.

NovaSure Model 10 RF Controller Screen Icons

The following is a description of the icons on the NovaSure Model 10 RF

controller screen.

Settings Icon:

Press this button to display the

setting options for Language,

Brightness, and Volume.

Last Procedure Icon:

Press this button to display the

“Procedure Complete” Screen

and review the summary from

the last procedure.

Help Icon:

Press this button to display more information

regarding the current step of the procedure.

This icon will display an abridged version of

the IFU language.

NOTE: When the “Last Procedure” Icon is pressed, only the previous

procedure will be displayed. Information for procedures prior to the

most recent procedure will not be available.

NOTE: In the “Settings” screen, press the “-” or “+” buttons to

adjust the volume and brightness.

NOTE: The ﬁrst time the Model 10 RFC is turned on, the “Select Your

Language” screen will display. The default setting is in English. To

select another language, press the button with the name of that

language. Save the selection by pressing the ﬂashing green button.

The language selection will be retained. To change the language

selection after the initial setup, use the “Setting” screen. Press the

name of the language to change the language used on the screen

display. To save changes to the settings, press the ﬂashing green

button. To cancel a selection, press the blue “X” located at the

bottom left center of the screen.

Troubleshooting Most Common Alarms

CAVITY ASSESSMENT ALARM

If the cavity integrity assessment fails, a screen will display “Cavity

Assessment Failure” with an abridged version of the troubleshooting tips

below. The cause of the cavity integrity assessment (CIA) failure is the

inability to pressurize the cavity. It may be caused by:

1. Device leak: Ensure that the suction line desiccant ﬁlter has been

installed. Check all tubing connections to ensure that they are tightly

connected.

2. Leak at the external os of the cervix: Look for visible bubbles or a

“hissing” sound at the external os of the cervix.

Use the tab on the cervical collar to advance the cervical collar

towards the external os of the cervix to ensure there is a tight seal.

Perform the CIA test again. If the CIA test fails again, use a second

tenaculum to grasp the cervix around the sheath of the NovaSure

disposable device. Perform the CIA test again.

3. Uterine perforation: If a perforation is suspected, the procedure

should be terminated immediately.

NOTE: CO2 leakage may occur at the external cervical os due to the

presence of an over-dilated cervix. Visible bubbles or the “hissing”

sound of escaping gas may accompany CO2 leakage under either of

these conditions.

NOTE: When following the troubleshooting steps on the Model 10

RFC, press the “?” button on the screen and use the scroll buttons

on the right for more information. To get back to the main screen

18

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from the additional troubleshooting tips, press the “X” in the top

right corner of the screen.

If the cavity integrity assessment fails after reasonable attempts

to implement the troubleshooting procedure (step 2.36), abort the

procedure.

VACUUM ALARM

The Vacuum alarm occurs when the vacuum level is outside its speciﬁed

range. This can occur as a result of one or more of the following:

• An over-dilated cervix;

• Poor contact between the cervical collar and the external cervical os;

• The vacuum relief valve is in the closed position;

• An obstruction in the disposable device ﬁlter(s) (two) or desiccant; or

• An obstruction within the disposable device.

If the Vacuum check fails, a screen will display “Vacuum Failure” with an

abridged version of the following troubleshooting tips:

• Gently press a 2-3.5 mm uterine dilator or sound inside the vacuum

relief valve

• Check the cervical collar position, and reposition if necessary. Use the

tab on the cervical collar to advance the cervical collar towards the

external os of the cervix to ensure there is a tight seal. Verify that air is

not being drawn through the cervix by a loose ﬁt between the cervical

collar and the entrance to the cervical canal. If air is being drawn in

through the cervical canal, try to reposition the cervical collar and

disposable device shaft to prevent air ingress.

• Ensure the suction canister on the disposable device is vertical and the

device tubing is not draped over the patient’s leg.

• Check all tubing connections to ensure that they are tightly connected.

Check the push-on tubing connectors at the desiccant tube. Replace

the desiccant if it is pink. Ensure that the ﬁlter located near the

disposable connection on the vacuum feedback line is tightened.

• Reattempt ablation.

If the “Vacuum Failure” screen displays again:

• Disconnect the disposable device from the RF controller.

• Remove the disposable device and replace with a new disposable

device.

• Reattempt the ablation with the new device.

NOTE: When following the troubleshooting steps on the Model 10

RFC, press the “?” button on the screen and use the scroll buttons

on the right for more information. To get back to the main screen

from the additional troubleshooting tips, press the “X” in the top

right corner of the screen.

If the vacuum alarm occurs with the new device, abort the procedure.

NOTE: Removing the disposable device from the uterine cavity after

completing a cavity integrity assesment will require an additional

CIA test to be performed upon disposable device re-insertion

(whether or not the CIA previously passed) prior to initiating an

ablation.

CO2 canister low or empty

A screen will display “Replace CO2” with an image of the back of the

controller. An audible tone will be generated at a rate of 1 time per

second. Alarm messages that were present prior to the alarm will remain

in the same state during the replace CO2 event. Pressing the foot switch

will not turn off the audible alarm.

1. Replace the CO2 canister to stop the audible tone.

NOTE: It is not necessary to remove the disposable device from the

patient prior to replacing the canister.

2. Continue with the procedure.

ARRAY POSITION Alarm

The Array Position message displays when the array is not open fully.

The controller cannot perform ablation when Array Position message

displays. If the ARRAY POSITION alarm occurs, a screen will display

“Check Array” with an abridged version of the following troubleshooting

tips:

1. Gently move the proximal end of the disposable device and observe

if the Array Position message no longer displays. If it still displays,

proceed with the following:

2. Attempt gentle reseating of the NovaSure disposable device:

A. Partially retract the array into the sheath by releasing the

disposable device handle lock release button;

B. Pull the disposable device back slightly from the fundus;

C. Slowly redeploy the disposable device array while gently

rocking the disposable device back and forth and locking the

disposable device handles; and

D. Reseat the disposable device against the fundus using the

seating procedure described in steps 2.26 through 2.33.

3. If the uterus is retroverted, take special care to avoid perforation.

Apply gentle caudad traction to the cervix with the tenaculum, and

elevate the disposable device handle upward toward the ceiling

(in-line with the axis of the uterus) while performing the seating

procedure.

4. If the Array Position message still displays, fully retract the

disposable device array and remove the disposable device from the

patient.

5. Deploy the disposable device outside the patient’s body; ensure the

electrode array is undamaged and that the Array Position message

no longer displays.

6. Attempt reinsertion, redeployment and reseating of the disposable

device using the seating procedure described in section 2.0.

7. If the Array Position message still displays, replace with a new

disposable device.

8. If the Array Position message displays with a new disposable device,

terminate the procedure.

NOTE: When following the troubleshooting steps on the Model 10

RFC, press the “?” button on the screen and use the scroll buttons

on the right for more information. To get back to the main screen

from the additional troubleshooting tips, press the “X” in the top

right corner of the screen.

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Please turn to next page for the remainder of the Instructions for Use.

Additional Troubleshooting

Suspected uterine perforation

Prior to Application of Energy:

1. Terminate the procedure

2. Assure patient stability

3. Consider work-up for

perforation

4. Reschedule procedure,

if appropriate

During or after Application of

Energy:

1. Terminate the procedure

2. Assure patient stability

3. Rule out visceral injury

4. Reschedule procedure,

if appropriate

Array does not fully deploy and lock in uterus

1. Partially retract array into sheath (hold the front handle stationary

and pull the rear handle back and away from the patient);

2. Reposition the disposable device in the cavity;

3. Redeploy the array in cavity;

4. If the disposable device does not lock, remove it from the uterus;

5. Inspect the disposable device for damage;

6. Attempt to open the disposable device and lock it outside the patient;

7. If damaged, the replace disposable device;

8. If the disposable device is not damaged, reinsert it into the patient’s

uterine cavity and attempt deployment; and

9. If unable to deploy the disposable device to a minimum 2.5cm

cornu-to-cornu distance, terminate the procedure.

10. Consider uterine perforation as a possible cause for not deploying.

Difﬁculty closing and removing the disposable device

post-ablation

Conﬁrm that the lock release button is depressed:

• If so, gradually withdraw the disposable device from the patient.

• If not, press the lock release button and reattempt to close the

disposable device. If it is still difﬁcult to close, gradually withdraw the

disposable device from the patient.

“Procedure Complete” Screen does not appear on the Model 10

RFC at the end of a procedure

If power has not been applied for at least 30 seconds, the “Procedure

Not Complete” screen will appear on the Model 10 RFC.

Procedure Not Complete

1. Remove device from patient and deploy array

a. Confirm that array is NOT damaged

b. Confirm that array Position does NOT display

2. For more help press ?

if a and b are confirmed, reinsert device, and PRESS FOOT SWITCH

to reattempt treament.

If a problem is found, replace device and restart procedure.

1. Remove the NovaSure disposable device from the uterus after fully

retracting the disposable device array into the sheath:

A. Release the disposable device lock release button;

B. Hold the disposable device front handle steady; and

C. Pull the disposable device rear handle backward.

2. Inspect the disposable device for any damage. Fully deploy the

electrode array outside the patient, demonstrating that the message

does not display on the Model 10 RFCs.

3. If the disposable device is not damaged and the message screen

does not appear on the Model 10 RFC, reinsert, redeploy and

reattempt treatment.

4. If the problem persists, replace the disposable device with a new

disposable device.

5. Reattempt the procedure. If the problem persists, terminate the

procedure.

“RF ON” screen will not appear on the Model 10 RFC

1. If the NovaSure RF controller is plugged in, switched on, the ENABLE

button has been pressed and no power is delivered from the

controller when the foot switch is depressed, check the foot switch

connection. Also make sure the CAVITY ASSESSMENT has passed.

2. If the problem persists, terminate the procedure.

UP/DOWN values will not appear when pressing the appropriate

buttons

Make sure that the disposable device is connected to the controller.

The values will not appear unless the disposable device is properly

connected to the controller.

Replacement Instructions

The NovaSure RF controller uses a pair of fuses that are located on

a fuse carrier in the power input module. Type T5AH, 250V fuses are

used. The module can be accessed by using a slotted screwdriver to

pop open the fuse carrier door. If required, the fuse carrier may then be

removed and the fuses changed. Assembly is the reverse of these steps.

Any potentially defective NovaSure product must be returned to Hologic

for evaluation. Follow the instructions at the end of this manual in the

Service Returns section, for obtaining a returned materials authorization

number (RMA #). Do not discard the NovaSure disposable device.

Technical Speciﬁcations

NovaSure disposable device

1. The NovaSure disposable device does not contain latex.

2. The NovaSure disposable device is a Class III device by FDA

regulation.

3. The NovaSure disposable device is a Class IIB device according to

the Regulation (EU) 2017/74.

4. The NovaSure disposable device tip nominal diameter: 6mm.

5. The NovaSure disposable device overall dimensions:

19” x 6” x 12” (48.3cm x 15.2cm x 5cm).

6. The NovaSure disposable device has a voltage rating of 153V.

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