Hologic NovaSure Istruzioni per l'uso

Tipo
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 RatesIntent-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
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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
ENGLISH
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.
19
ENGLISH
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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Hologic NovaSure Istruzioni per l'uso

Tipo
Istruzioni per l'uso