NovaSure Instructions for Use and Controller Operators Manual Rev 014 Jan 2021

ENGLISH NovaSure Model 08-09 RF Controllers

NovaSure Disposable Device Description 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.

NovaSure Model 10 RF Controller

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. NovaSure RF Controller Description

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 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 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.

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).

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ENGLISH • 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.

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 16gram 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.

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.

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.

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.

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: MAN-03523

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ENGLISH 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. • 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.

• 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 (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 metal micro-insert must be confirmed prior to performing the NovaSure procedure.

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 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.

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. The risk of reusing the disposable device includes but is not limited to the following: • ineffective procedure • infection (major) • electric shock • transmission of communicable disease • cervical laceration • uterine perforation • 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 MAN-03523

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ENGLISH 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.

• 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 the ARRAY POSITION LED light is illuminated on Models 0809, or 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 MAN-03523

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 NovaSure Adverse Event

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 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%)**

Adverse Event

* Nine events reported in 6 (3.4%) patients ** Five events reported in 4 (4.4%) patients

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ENGLISH Other Adverse Events As with all endometrial ablation procedures, serious injury or death can occur.

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

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%)**

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

* Five events reported in 4 (2.3%) patients ** Seven events reported in 6 (6.7%) patients

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.

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

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%)

21 (12.0%)*

15 (16.17%)**

TOTAL

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.

* 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 postoperative 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 MAN-03523

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

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ENGLISH 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:

Table 2. Patient Accountability Number of Patients

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. MAN-03523

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*

-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*

-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

2

2

* 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

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ENGLISH (described in Table 2 for patient accountability) is counted as a “failure” for calculating the values listed in the table.

Table 4. Effectiveness: Quality of Life (QOL) Wire Loop Resection NovaSure Plus Rollerball Percent of Patients Reporting Sometimes, Frequently Or Always Have Difficulty Performing Work Or Other Activities Due to Menses 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%*

Table 3. Effectiveness: Success Rates–Intent-To-Treat Patients Wire Loop Resection Plus Rollerball (n=90)

NovaSure (n=175) 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 Amenorrhea rate

63

64

58

29

26

23

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.

# 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)

Table 4. Effectiveness: Quality of Life (QOL) Wire Loop Resection NovaSure 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%* MAN-03523

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)

4.2 ± 3.5**

24.2 ± 11.4**

84.0 ± 25.0

ND#

(Device insertion to device removal) Procedure time in seconds (±SD) (Time of energy delivery) * See Table 2 for patient accountability ** Statistically significant difference between treatment groups (Student’s t-test; p < 0.05) # Not determined

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ENGLISH 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.

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).

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.

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%

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.

* 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.

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.

Table 7. 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

11 (6.3%)

4 (4.4%)

Reason For Hysterectomy

TOTAL

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.

7 Hysterectomies were in patients <40 years (7 NovaSure) and 8 hysterectomies were in patients >40 years (4 NovaSure; 4 Rollerball).

Active bleeding was not found to be a limiting factor when using the NovaSure system. It is recommended that a nonsteroidal antiinflammatory drug (NSAID) be given at least one hour prior to treatment and continued postoperatively to reduce intraoperative and postoperative uterine cramping.

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 techniques, indications, contraindications, complications and hazards prior to the performance of any endometrial ablation procedure.

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ENGLISH NovaSure Impedance Controlled Endometrial Ablation System Instructions For Use Please read all instructions, cautions and warnings prior to use.

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.

1.0 Set-up

Toggle switch

AC power cord NOVASURE DISPOSABLE DEVICE WITH CONNECTING CORD, INCLUDING SUCTION LINE DESICCANT

NOVASURE RF CONTROLLER

NOVASURE POWER CORD

NOVASURE SUCTION LINE DESICCANT

NOVASURE CO2 CANISTER

NOVASURE FOOT SWITCH

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.

Port

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. Lock Release Button WIDTH Dial

Rear Handle

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”.

Cavity Length Setting Vacuum Relief Valve Cervical Collar

Suction Line

Vacuum Feedback Line Barb Front Handle

Sheath

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.

Bipolar Electrode Array

NOTE: Please have available at least one extra disposable device, desiccant assembly and CO2 canister. MAN-03523

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ENGLISH 2.5 2.6 2.7 2.8

Prepare and drape patient similar to prep for D&C. Insert a speculum into the vagina. Grasp the cervix with a tenaculum. 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.

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.

TABLE 8. CAVITY LENGTH Uterine Sound (cm) Cervix Length (cm)

10

9.5

9

8.5

CAUTION: The suction line desiccant is non-sterile and the packaging should not be placed in the sterile field.

8

7.5

7

6.5

6 4

2

6.5* 6.5*

6.5*

6.5

6

5.5

5

4.5

2.5

6.5* 6.5*

6.5

6

5.5

5

4.5

4

4

3

6.5*

6.5

6

5.5

5

4.5

3.5

6.5

6

5.5

5

4.5

4

4

6

5.5

5

4.5

4

4.5

5.5

5

4.5

4

4

5

5

4.5

5.5

4.5

4

6

4

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.

* The value of 6.5 is not intended to reflect the numerical difference between the sound length and the length of the cervical canal.

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.

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.

Disposable Device Port

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ENGLISH 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. The NovaSure RF controller CAVITY ASSESSMENT LED flashes red (Model 08-09 RFCs) or a purging device message displays (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.

ARRAY CLOSED indicator

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.

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.

WARNING: Use caution not to perforate the uterine wall when sounding, dilating or inserting the disposable device.

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.

2.16 Deploy the disposable device outside of the patient and ensure the controller ARRAY POSITION LED is extinguished (Model 08-09 RFCs) or the screen message does not display (Model 10 RFC) when the array is opened. If the LED is not extinguished (Model 08-09 RFCs) or the screen message is still displayed (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

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.

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.

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ENGLISH 2.28 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 45° counterclockwise from the vertical plane and 45° clockwise from the vertical plane until the handles lock. The WIDTH dial should read greater than 2.5 cm. NOTE: Once the disposable device handles are locked, the uterus should move in conjunction with the disposable device. #1

0

2.29 Gently move the disposable device using anterior, posterior and lateral movements. 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 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. 0.5 cm 2.30 To complete placement, slightly pull back the disposable device until the WIDTH dial reading reduces by approximately 0.2–0.5 cm.

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ENGLISH 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.

Gentle pressure

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.

Slight pressure

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. INCORRECT PLACEMENT

CORRECT PLACEMENT

Fundus

Fundus

Electrode Array

Endocervical Canal

Electrode Array Sheath Edge Endocervical Canal

Sheath Edge

Sheath edge resides in lower uterine segment

Sheath edge resides in endocervical canal

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ENGLISH

MODEL 08-09 RF CONTROLLERS

MODEL 10 RF CONTROLLER

Follow next steps on pages 16 through 19.

Follow next steps on pages 20 through 23.

Table of Contents for both Models 08-09 and Model 10 RF Controllers Additional Troubleshooting ���������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 24 Replacement Instructions ������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 24 Specifications ������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 25 Cleaning and Sanitizing ��������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 28 Parts List �������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 28 Warranty �������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 29 Technical Support and Product Return Information ������������������������������������������������������������������������������������������������������������������������������������������� 29 Symbol Definitions. ���������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 30

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ENGLISH

Model 08-09 RFC USERS ONLY

Operating the Model 08-09 RF Controllers

cervical collar, use another tenaculum to grasp the cervix around the sheath. Repeat the CIA 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 (whether or not the CIA previously passed) prior to initiating an ablation.

A. Automatic mode To operate the system in automatic mode, press the ENABLE button prior to beginning the Cavity Integrity Assessment (CIA). Proceed to step 2.36, but do not follow step 2.37 if operating the system in automatic mode.

2.37 Manual mode only When operating the system in manual mode, the ablation cycle will not start automatically after the successful completion of the 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 some Model 09 RF controllers, a vacuum pre-check occurs automatically prior to initiation of the ablation cycle. The VACUUM LED will flash and an audible tone will be heard for up to 10 seconds during the vacuum pre-check.

B. Manual mode To operate the system in the manual mode, do not press the ENABLE 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. The CAVITY ASSESSMENT LED flashes green in conjunction with an audible tone at a rate of once per second when the system is performing a CIA. The duration of the test will range between approximately 7 and 30 seconds. A steady green LED appears when the CIA has passed and the system can deliver RF energy. Power cannot be applied to the disposable device until the CAVITY ASSESSMENT LED is a steady green light. If the cavity integrity assessment fails, then the CAVITY ASSESSMENT LED on the NovaSure RF controller will flash red, and a rapid audible tone will sound at a rate of four times per second.

MANUAL MODE

During the ablation cycle, a blue RF ON LED will illuminate. At the completion of the ablation cycle, the RF power delivery (RF ON LED), as well as suction, will switch off automatically. The physician can stop the progress of the procedure at any time by depressing the foot switch. NOTE: RF power delivery can be stopped at any time by pressing the foot switch

If the cavity integrity assessment fails, press the foot switch to stop the sound. Next:

2.38 After automatic termination of the ablation cycle (approximately 90 seconds), fully retract the cervical collar by using the tab on the cervical collar. Fully retract the cervical collar by sliding it to its proximal position.

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 MAN-03523

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ENGLISH biohazardous waste and disposed of according to standard practices of the hospital or clinic where the treatment is performed. 2.43 Discharge the patient from the hospital or office as indicated by the managing physician.

Cervical Collar

Periodic Maintenance and Service 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. Periodic maintenance 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.

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. (See step 2.18.) 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.”

RF power output test The NovaSure RF controller Model 08-09 integrates automatic power output testing into 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.

CAUTION: To avoid damaging the device, employ gentle technique when retracting the array.

Model 08-09 RFC USERS ONLY

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.

NOTE: If a NovaSure disposable device is connected at the time the controller is powered up, the POST will not be performed and the controller will return to normal operation. If a device is connected during the POST sequence, the POST will terminate and the controller will return to normal operation. The following procedure is used to execute the POST and display the actual value of Pc and Rs determined: 1. With the switch on the power input module in the off position, check to make sure a disposable device is not connected to the RF controller. 2. Depress and hold the length UP and length DOWN arrows simultaneously, then toggle the power switch at the power input module while continuing to depress the arrows. This step initiates the POST, which proceeds automatically. 3. Upon the completion of the POST (approximately 5 seconds), the RF controller will generate one audible tone, and then display the actual value of Pc for two seconds on the power set LED. 4. After two seconds elapse, the power set LED will change to display the actual value of Rs for two seconds. 5. The power set LED will then change to 00, and the RF controller will return to normal operation without further input from the user. The acceptable limits on Pc = 180 W ± 10%. If Pc is not within specification, a system fault will occur. The actual value of Rs is for reference only.

2.40 Withdraw the disposable device from the patient.

2.41 Turn off the NovaSure RF controller. Close the CO2 regulator. 2.42 Perform postoperative patient care according to standard procedures. The used disposable device must be treated as MAN-03523

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ENGLISH

Model 08-09 RFC USERS ONLY

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 customer service.

1. Flashes red accompanied by an audible tone while the system is stabilizing the vacuum level for up to 10 seconds before energy delivery commences (only for Model 09 controllers with a vacuum pre-check function). 2. Illuminates red when the vacuum relief valve is stuck in the closed position, when a blockage is detected in the disposable device or the connection tubing or when the system has a leak. Such a situation might be created by: • an over-dilated cervix with poor contact between the cervical collar and the external os; • a poor attachment of the desiccant tube to the suction tubing; • an obstruction in the disposable device tubing; or • an obstruction in the disposable device. SYSTEM FAULT LED: illuminates red if the system faults or if there is a self-diagnostic check failure with the system clock or power delivery. If this event occurs, terminate the procedure immediately and contact an authorized Hologic service representative for instructions.

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 RF Controller LED Descriptions The following is a description of the alert LEDs on the NovaSure RF controller. CAVITY ASSESSMENT LED: illuminates in four modes: 1. Flashes red in conjunction with an audible tone at a rate of once per second for the first 10 seconds when the system is purging air out of the disposable device. After 10 seconds, the LED and audible tone will cease, although CO2 will continue to flow out of the vacuum feedback line. 2. Flashes green in conjunction with an audible tone at a rate of once per second when the system is performing a cavity integrity assessment. 3. Steady green light appears when the cavity integrity assessment has passed and the system can deliver RF energy. Power cannot be applied to the disposable device until the CAVITY ASSESSMENT LED is a steady green. 4. Steady red lights and an audible tone at a rate of four times per second occur when the cavity integrity assessment has failed. The CIA test may be tried again. ENABLE LED: illuminates amber when the user presses the ENABLE button. Acts as a safety so that the NovaSure disposable device will not accidentally activate when the foot switch is touched. The ENABLE LED will not illuminate when the ARRAY POSITION LED is on.

Troubleshooting Most Common Alarms CAVITY ASSESSMENT LED illuminated red If the CAVITY ASSESSMENT LED is steady red, the cavity integrity assessment has failed. If the cavity integrity assessment fails, then the CAVITY ASSESSMENT LED on the NovaSure RF controller will flash red, and a rapid audible tone will sound at a rate of four times per second. The CIA test may be tried again. If a perforation is suspected, the procedure should be terminated immediately. If the cavity integrity assessment fails, press the foot switch to stop the sound. The cause of the cavity integrity assessment 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. Test again. If the test fails again, use a second tenaculum to grasp the cervix around the sheath of the NovaSure disposable device. Test again. 3. Uterine perforation: If a uterine 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.

RF ON LED: illuminates blue when the ablation is proceeding (the foot switch has been depressed to activate the NovaSure RF controller with the NovaSure disposable device array in place in the uterus). PROCEDURE COMPLETE LED: illuminates when the tissue impedance reaches 50 ohms and the ablation procedure runs a minimum of 30 seconds. ARRAY POSITION LED: illuminates red when one pole of the electrode array may be in contact with another. This LED should be illuminated when the array is not fully deployed. The ENABLE LED cannot be toggled on, nor can power be delivered to the array when the ARRAY POSITION LED is illuminated. VACUUM LED: illuminates in two conditions: MAN-03523

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ENGLISH

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

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.

VACUUM LED illuminated The VACUUM LED illuminates when the vacuum level is outside its specified range. This can occur as a result of one or more of the following:

2. Continue with the procedure.

ARRAY POSITION LED illuminated 1. Gently move the proximal end of the disposable device and observe if the ARRAY POSITION LED extinguishes. If it does not, 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 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 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 LED is still illuminated, 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 LED extinguishes. 6. Attempt reinsertion, redeployment and reseating of the disposable device using the seating procedure described in section 2.0. 7. If the ARRAY POSITION LED remains illuminated, replace with a new disposable device. 8. If the ARRAY POSITION LED remains illuminated with a new disposable device, terminate the procedure.

• 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. To eliminate this condition, perform the following: • Gently press a 2–3.5 mm uterine dilator or sound inside the vacuum relief valve. • Check the cervical collar position, and reposition it 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 dessicant 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 LED illuminates again: • Disconnect the disposable device from the RF controller. • Remove the disposable device from the patient, then; • Exchange the disposable device with a new disposable device. • Reattempt the ablation with the new device. If a vacuum alarm occurs with the new device, abort the procedure:

Please turn to page 24 for the remainder of the Instructions for Use.

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

MAN-03523

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CO2 canister low or empty The NovaSure RF controller will generate an audible tone at a rate of four times per second during this alarm condition. LEDs that were illuminated prior to the alarm will remain in the same state during the low CO2 event. Pressing the foot switch will not turn off the audible alarm.

If the cavity integrity assessment fails after reasonable attempts to implement the troubleshooting procedures (step 2.36), abort the procedure.

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ENGLISH

Model 10 RFC USERS ONLY

Operating the Model 10 RF Controller

C.

A. Automatic mode

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.

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

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

During the ablation cycle, an “RF ON” screen with a timer will appear to track the duration of the ablation.

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. MAN-03523

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. Cervical Collar

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