THERMACHOICE II Operating Manual

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GYNECARE THERMACHOICE II System Operating Manual

Page 39

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Table of Contents

Page Device Description Indications Contraindications Warnings Precautions Adverse Events Other Adverse Effects Clinical Trial Patient Population Patient Selection ... 14 Patient Counseling Pretreatment Preparation of Patient Directions for Use Set-up Catheter Priming Pressure Titration Treatment Post-Treatment ... 22 Operating Parameters/ Alarm and Display Messages ...22 Error Messages ... 23 Warranty Servicing/Equipment Disposal Ordering Information Specifications (Controller & Umbilical Cable) ...25 Environmental Conditions Electromagnetic Interference Maintenance Calibration Fuse Replacement Cleaning: Controller System Disinfection: Umbilical Cable Power Cord Page 38

GYJECARE THERMACHOICE eBT System Operating Manual

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GYNECARE THERMACHOICE II System Operating Manual

Page 37

gY~~fD~~D~

Error Code Table 62

PRESSURE ERR62XX END PROCEDURE REMOVE FLUID REMOVE CATHETER

63

PRESSURE ERR63XX END PROCEDURE REMOVE FLUID REMOVE CATHETER

64

HEATER ERR64XX END PROCEDURE

Under-pressure: Pressure <70 mmHg for 2 seconds.

Over-pressure: Pressure >210 mmHg for 2 seconds.

Check catheter for possible leaks. Replace if needed. Rapid drop in pressure may indicate possible u terineperforation. Rule out perforation before proceeding. Careful titration may lead to more stable pressure during theraEl Keep catheter centered in uterus. Ensure proper priming to eliminate air from balloon and allow balloon to be fullr o,E:en.

Fluid temperature <87 QC during entire 4 minute preheat cycle.

Return controller to GYNECARE for service.

HEATER ERR65XX END PROCEDURE

Ca t)leter malfunction

Possible catheter failure. Turn power off to clear error message and replace catheter.

REMOVE FLUID REMOVE CATHETER 66

UNDERHEAT ERR66XX END PROCEDURE

Fluid temperature <75 QC for 15 seconds.

Return controller to GYNECARE for service.

REMOVE FLUID REMOVE CATHETER 67

UNDERHEAT ERR67XX END PROCEDURE

Pressure transducer

Return controller to GYNECARE for service.

CATHETER ERR68XX END PROCEDURE

Fluid temperature did not rise -6 QC within 30 seconds.

REMOVE FLUID REMOVE CATHETER

Possible catheter faiJure.Turn power off to and replace catheter. clear error message Procedure can continue without circulation. Avoid loops, kinks or bends in pressure line from controller to catheter to reduce the potential for motor fault issues.

MOTOR FAULT

-

N,'Ne.

Somerville, New Jersey 08876-0151

7TM1E~MACHOICE* Uterine

Balloon

Therapy

Thermal Balloon Ablation System Read all directiQns, precautions and warnings prior to use. This manuai provides directions for using the GYNECARE THERMACHOICE Uterine Balloon Therapy (UBT) System.

DEVICE DESCRIPTION The GYNECARE THERMACHOICE UBT System is a software-controlled device designed to ablate uterine tissue by thermal energy. The system is comprised of a single-use balloon catheter, a reusable controller, umbilical cable, and power cord. The GYNECARE THERMACHOICE UBT catheters are designed for use only with GYNECARE THERMACHOICE UBT controllers. The balloon catheter is 1) connected to the controller, 2) inserted through the cervix into the uterus, 3) filled with sterile, injectable fluid (plain 5% dextrose in water- D,W) carefully stabilizing the pressure to 160-180mmHg pressure, and 4) activated to thermally ablate endometrial tissue by maintaining a temperature of approximately 87°C (188°F) for 8 minutes. The GYNECARE THERMACHOICE UBT controller is designed to work with 3 different versions of the balloon catheter. They are:

REMOVE FLUID REMOVE CATHETER 68

le 0

a ~1..g.or1-1f,Hm, company

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician with appropriate training.

REMOVE FLUID REMOVE CATHETER 65

AdivisionolETH

r

--

---

---

a)

GYNECARE THERMACHOICE IIIC silicone balloon catheter (version 3.0): This balloon catheter has a fluid circulation mechanism inside the balloon (See Diagram 1).

b)

GYNECARE THERMACHOICE IIC silicone balloon catheter (version 2.0): This balloon catheter has a fluid circulation mechanism inside the balloon (See Diagram 2).

cl

GYNECARE THERMACHOICE balloon catheter (version 1.2): This version does not have a fluid circulation mechanism inside the balloon (See Diagram 3).

Caution: The GYNECARE THERMACHOICE balloon catheter version 1.2 (only) contains natural rubber latex which may cause allergic reactions.

INDICATIONS The GYNECARE THERMACHOICE UBT System is a thermal ablation device intended to ablate the endometrial lining of the uterus in women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

Page 36

GYNECARE THERMACHOICE UBT System Operating Manual

Page 1

Error Code Table Diagram 1 GYNECARE THERMACHOICE mc Single Use Silicone Balloon Catheter with Fluid Circulation (Version 3.0) and Umbilical Cable

56

Fluid fill port for syringe 57

r

Catheter malfunction

Possible catheter failure. Turn power off to clear error message and reElace catheter.

Catheter malfunction

Possible catheter failure. Turn power off to clear error message and reElace catheter.

Catheter temperature sensing error

Keep catheter centered in uterus. Check umbilical connections.

Overheat error Fluid temperature between 90 °C and 95 °C for 15 seconds.

Keep catheter centered in uterus. Check umbilical connections. Ensure proper priming to elimina te air from balloon and allow balloon to be fully open. If error persists, return controller to GYNECARE for service.

Overheat error Fluid temperature >95 QC for 2 seconds.

Keep catheter centered in uterus. Check umbilical cmmections. Ensure proper priming to eliminate air from balloon and allow balloon to be fully open. If error persists, return controller to GYNECARE for service.

Overhea terror Fluid temperature >105 °C for 2 seconds.

Keep catheter centered in uterus. Check umbilical connections. Ensure proper priming to elimina te air from balloon and allow balloon to be fully open. If error persis ts, return controller to GYNECARE for service.

REMOVE FLUID REMOVE CATHETER

Depth, sound measurement (cm) Fluid fill valve (Trumpet valve)

CATHETER ERR56XX END PROCEDURE

CATHETER ERR57XX END PROCEDURE REMOVE FLUID REMOVE CATHETER

cable connection 58

Circulating element

CATHETER ERR58XX END PROCEDURE REMOVE FLUID REMOVE CATHETER

59 Front Panel of Controller Catheter heater temperature display (0C)

REMOVE FLUID REMOVE CATHETER

Umbilical cable

Intra-balloon pressure display (mmHg)

OVERHEAT ERR59XX END PROCEDURE

Start button Message display

~~7J~~t.,~,~f!~~~

60

g_'::.~f;S/:.~;l

~

i

REMOVE FLUID REMOVE CATHETER

L

L Total time display (minutes: seconds) COlmection port for reuseable umbilical cable Connection port for pressure line (pre-attached to single use balloon catheter) Connection port for circulation catheter (pre-attached to single use catheter) NOTE: Remove the plug before connecting the circulation catheter.

Power switch

OVERHEAT ERR60XX END PROCEDURE

Stop button

61

OVERHEAT ERR61XX END PROCEDURE REMOVE FLUID REMOVE CATHETER

Fuse

Rear Panel of Con troll er

c:::::::lC==>c::::::Jc::::::JC:::::>c::=lC:=>C:::::>C::=>c:::::::lc::::::Jc::JC::::::>C:::::>C:::::>c:::::><=lc:::::::lC=><=l c:::::::lC==>c::=Ic::::::>C==>c::::::Jc::=:lc::::::>c::::::>c::::::>c:::::>c::::::JC::::::>C::::::>c::::::Jc::::::Jc::::::Jc:::::::lc::::>c::::::J

I

~.::~: ;;;:::: ; ;;;::::;;;;:::

rxl lAJ

"_ 000 """,_",.".. ".",

~~~~: ~~:~:;;:~;;;;:;: ~~;:::

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I~~ ~-="'~'~=-':' rm.' IC~_ ~~,:.. ~ -=--===-~==--

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-

, ... ­

Connection port for AC power cord

Page 2

GYNECARE THERMACHOICE UBT System Operating Manual

Page 35

For immediate technical! clinical support, call 1-877-ETHICON (U.S. and Canada customers) Error Code Table ERROR CODE 01

02

03

50

51

52

DISPLAYED TEXT SYSTEM ERR01XX TURN POWER OFF

SYSTEM ERR02XX TURN POWER OFF

SYSTEM ERR03XX TURN POWER OFF

CATHETER ERR50XX REPLACE CATHETER

CATHETER ERR51XX REPLACE CATHETER

CATHETER ERR52XX REPLACE CATHETER

Front panel of Controller

REASON

ACTION

Controller malfunction

Turn power switch off and REMOVE CATHETER then on again. If error message persists,return to GYNECARE for service.

Controller malfunction

Controller malfunction

Catheter malfunction

Catheter malfunction

Catheter malfunction

REMOVE FLUID REMOVE CATHETER 53

54

DESCRIPTION OF SYMBOLS

Turn power switch off and then on again. If error message persists,return controller to GYNECARE for service. Turn power switch off and then on again. If error message Gynecare for service. persists, return controller to GYNECARE for service. Possible catheter failure. Turn power off to clear error message and reElace catheter. Possible catheter failure. Turn power off to clear error message and reElace ca theter. Possible catheter failure. Turn power off to clear error message and reElace catheter.

OVERHEAT ERR53XX END PROCEDURE

Fluid temperature between 90 QC 95 QC for 15 seconds.

Return controller to GYNECARE for service.

CATHETER ERR54XX END PROCEDURE

Fluid temperature >95 QC for 2 seconds.

Return controller to GYNECARE for service.

o I

Off (power: disconnection from the mains)

On (power: connection to the mains) Start Button

A INSERT CATHETER FILL CATHETER

WITHDsW

@

Stop Button

When symbol is illuminated, a hazard condition exists which will automatically terminate procedure (see ERROR MESSAGES section)-<:onsult Operator's Manual for further instruction. An unilluminated symbol indicates normal operating conditions. Message Display-displays prompts and error messages

®

Displays pressure ll1side balloon in mmHg

!

Displays heater temperature inside balloon in QC

e)

Displays total running time for preheat and therapy in MINUTES: SECONDS

@

Circulation ca theter connection port

Rear Panel of Controller (See SPECIFICATIONS for additional information.)

B­

Connection port for power cord

~

Location of fuses; type and value rating

V

Equipotentiality

~ &

Class I Type BF Equipment

Cover to be removed by qualified service personnel only

CAUT ION

REMOVE FLUID REMOVE CATHETER 55

CATHETER ERR55XX END PROCEDURE REMOVE FLUID REMOVE CATHETER

-

Page 34

Danger: Risk of explosion if used in the presence of flammable anesthetics! Catheter malfunction

Possible catheter failure. Turn power off to clear error message and replace catheter.

~ ~0086

CE-Mark and identification number of Notified Body. Product conforms to the essential requirements of the Medical Devices Directive 93/ 42/EEC.

- - ­

GYNECARE THERMACHOICE UBT System Operating Manual

Page 3

Diagram 2 GYNECARE THERMACHOICE nc Single Use Silicone Balloon Catheter with Fluid Circulation (Version 2.0) and Umbilical Cable Depth, sound measurement (cm)

~IUid fill valve

Silicone balloon/

/

~

Fluid fill port for syringe

(Trumpet valve)

er-=-

=:J

3.0 CLEANING: CONTROLLER SYSTEM

Catheter umbilical cable connection

Circulating element

Over pressure relief valve

Front Panel of Controller Catheter heater temperature display roC)

'",- Umbilical cable

The GYNECARE THERMACHOICE UBT umbilical cable is packaged non-sterile. After each use, the cable should be disinfected. To disinfect, wipe down the cable with a damp cloth using a solution 70% isopropyl alcohol. Ensure the cable and connectors are completely dry. Inspect the cable and the connector plugs before each use for signs of wear and replace if necessary. The umbilical has been validated for 20 cycles. Following 20 uses, discard the cable, and replace.

Message display

Y.~~,~~~~~:~!

· . LL

9,~~!..~ ."..~! 1

Power switch

It is good practice to routinely clean the exterior surface of the device. 1. Disconnect all umbilical cables and unplug the power cord from the wall outlet before cleaning. 2. Use a cloth dampened with 70% isopropyl alcohol, or a mild, nonabrasive detergent (such as commercially available dish cleaning liquid) mixed with water. 3. Periodically clean the entrance of the controller's port (Iuer lock) using a cotton swab with 70% isopropyl alcohol. Do not autoclave, ETO sterilize, or immerse the controller or umbilical cable in a liquid. Do not allow liquids to enter the controller during cleaning. 4.0 DISINFECTION: UMBILICAL CABLE

Intra-balloon pressure display (mmHg)

~

Replace both fuses with the same type and rating as specified on the rear of the controller. Reinsert the fuse drawer until the locking tab snaps into place. Reconnect the power cord and restore power to the controller. If a fuse fails again, disconnect all power to the controller and return it to GYNECARE. All other service must be performed by appropriately qualified technical personnel. Field repair, other than the controller's external fuse replacement, voids all warranties and may not be performed without express authorization from GYNECARE.

5.0 POWER CORD

L. Total time display (minutes: seconds) Connection port for reuseable umbilical cable

COImection port for pressure line (pre-attached to single use balloon catheter)

Stop button

Users in North America operating from a nominal 120 VAC system must select a Type SJT, SJTO, SJO, or SJE, Hospital Grade cord set. The power supply cord must be marked "Grounding Reliability can only be achieved when the equipment is connected to an equivalent receptacle marked 'Hospital Grade' or 'Hospital Only.'"

COIm.ection port for circulation catheter (pre-attached to single use catheter) NOTE: Remove the plug before cOlmecting the circulation catheter. Fuse

Rear Panel of Controller

~C:>C::::::>C::::::>C::::::>C::::::>C::::::>C::::::>C::::::>C::::::>C::::::>C::::::>C::::::>C::::::>C::::::>c::=lC:>c:::JC:>c:::J c:::::JC:>C:>c:::::JC:>c:::JC:>C:>c:::::JC:>C:>C:>C:>C::::::>c:::::J~c:::::JC:>C:>C:>

;;!::m~!::~m:um

11 £t y~~~&~~'

~

I'@:~;~-=~ .@ ((~- rt¥:~~ 1

Comlection port for AC power cord

Page 4

GYNECARE THERMACHOICE II System Operating Manual

Page 33

Procedure

1.1.2 1.

With no attachments to the luer lock, apply power to the controller. The pressure display should read 0+10 mmHg. 2. Assemble the digital pressure gauge, the tubing, the T connector, the trumpet valve, the male luer lock adapter, and the syringe as shown in Diagram 6, and connect to the connection port (luer lock) of the controller. 3. While depressing the trumpet valve" apply vacuum to the system using the syringe until the gauge reads approximately -250 mmHg. 4. Release the trumpet valve. The controller pressure reading should be within +10 mmHg of the gauge reading 5. While depressing the trumpet valve, apply pressure to the system until the reading on the digital display meter indicates a pressure of approximately 250mmHg. 6. Release the trumpet valve. The controller pressure reading should be within +10 mmHg of the gauge reading. 1.2 TEMPERATURE CALIBRATION 1. 2.

Obtain a calibrated digital or glass thermometer. Place this thermometer in close proximity to a new GYNECARE THERMACHOICE UBT catheter tip and allow them to come to thermal equilibrium with the ambient. 3. Connectthe catheter to the controller using the umbilical cable as described earlier in the manual. 4. Power up the controller. 5. Note the thermometer reading and compare to that of the controller. The readings should be within +5 degrees Celsius. 6. Insert the balloon end of the catheter along with the thermometer in 80-90 degrees Celsius water. 7. Allow a few minutes for the catheter and the thermometer to come to thermal equilibrium. 8. Compare the two temperature readings. They should be v.'.ithin +5 degrees Celsius. 2.0 FUSE REPLACEMENT Fuse: In the event of a main fuse failure, turn off the power and unplug the rear of the controller to allow fuse access. Using a tool such as a screwdriver, remove the fuse drawer by depressing the locking tab. See Diagram 7 below: Diagram 7

...Use a tool to depress ; the locking tab

Mains Fuse Drawer -

Diagram 3 GYNECARE THERMACHOICE Single Use Balloon Catheter (Version 1.2) and Umbilical Cable

!

Depth, sound measurement (cm)

Latex balloon

Fluid fill valve (Trumpet valve)

Heater

OOIlIIIID~ Umbilical cable

~

Front Panel of Cont1'01ler Catheter heater temperature display (0C) Inh'a-balloon pressure display (mmHg)

Message display

r-

Po"ver, switch

Connection port for reusable umbilical cable Connection port for pressure line (pre-atta ched to single use balloon catheter) Connection port for circula tion ca theter (pre-attached to single use catheter) NOTE: Do not remove the plug. The circulation port is not used for this version of the catheter. Rear Panel of Controller

Fuse

r';

C:::::::>c:::::::JC:::::::>c:::::::JC:::::::>C::::::::>C:::::::>C:::::::>c:::::::>C::::::::>C:::::::>C:::::::>C:::::::>c::::::Jc:::::::JC:::::::>C:::::::>C:::::::>C:::::::>C:::::::> c:::::::>c:::::::>c:::::::>c:::::::>c:::::::>c::::::::>c:::::::>c:::::::>c:::::::>c:::::::>c:::::::>c:::::::>c:::::::>c:::::::>c:::::::>c:::::::>c:::::::>c::::::::>c:::::::>c:::::::>

- ' 0'1.

Mains Fuse (" type and rating" - - ~.

.

-- ...,...

I'

- -;~

I

.

..

~J<--.'

I

Page 32

i':YNE C A REY

!j~~

Connection port for AC power cord

!

I

k.

~ ='._. n.i:.!.:.r..~ '

I ~~:~~~~ .i: I(cL :~~~ ~ ~

.~. ,-;. ·1

".

. 1'

:,;,:~.: ;; ; ;;;;;;;;;;;;::;::;;

'~ f;.: :::::::::::::::::::::::

,.1._"

,,~_

.. ~:-~ ,/

GYNECARE THERMACHOICE UBT System Operating Manual

Page 5

CONTRAINDICATIONS

MAINTENANCE

The device is contraindicated for use in:

1.0 CALIBRATION

• • •

•

•

Every time the GYNECARE THERMACHOICE UBT System is powered up, the controller checks the calibration of the temperature circuitry. The pressure measurement in the system is accomplished by utilizing two transducers. These transducers are internally calibrated and are temperature compensated which are accurate and stable over the operating range. They are also factory calibrated at installation. These pressure readings are checked against each other at power up and throughout the procedure. These sensors are of differential type, and therefore measure the balloon pressure relative to the outside atmosphere. In addition to the internal means of calibration, it is possible to ensure the proper operation of the system against other calibrated devices. The procedure is recommended to be performed on an annual basis. The procedure also needs to be carried out if it is believed that the system is behaving unexpectedly.

A patient who is pregnant or who wants to become pregnant in the future. A patient with a history of latex allergy or who has demonstrated a sensitivity to latex material (for catheter version 1.2 only). A patient with known or suspected endometrial carcinoma (uterine cancer) or pre-malignant change of the endometrium such as unresolved adenomatous hyperplasia. A patient with any anatomic or pathologic condition in which weakness of the myometrium could exist, such as history of previous classical cesarean sections or transmural myomectomy. A patient with active genital or urinary tract infection at the time of procedure (e.g., cervicitis, vaginitis, endometritis, salpingitis, or cystitis). A patient with an intrauterine device (IUD) currently in place,

Note: There are no calibration adjustments on the controller. If the unit does not meet the calibration requirements, it needs to be sent back to the manufacturer.

WARNINGS Failure to follow all instructions or to heed any warnings or precautions could result in serious patient injury. • The device is intended for use only in women who do not desire to bear children because the likelihood of pregnancy is significantly decreased following this procedure. There have been reports of women becoming pregnant following this procedure. Pregnancies after ablation can be dangerous for both mother and fetus. • Endometrial ablation using the GYNECARE THERMACHOICE UBT System is not a sterilization procedure. • Patients who undergo endometrial ablation procedures who have previously undergone tuballigation 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. • Endometrial ablation procedures using the GYNECARE THERMACHOICE UBT System should be performed only by medical professionals who have experience in performing procedures within the uterine cavity, such as IUD insertion or dilation and curettage (D&C), and who have adequate training and familiarity with the GYNECARE THERMACHOICE UBT System. • Endometrial ablation procedures do 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. • The GYN ECARE THERMACHOICE III UBT Balloon Catheter is for single use only­ do not reuse or resterilize. • Do not treat patients for more than one therapy cycle in a given treatment session because of the potential for transmural injury to the uterus or injury to adjacent viscera. • UTERINE PERFORATION • Uterine perforation can occur during any procedure in which the uterus is instrumented. Use caution not to perforate the uterine wall when sounding the uterus, dilating the cervix or inserting the catheter. • Any of the following indicates possible uterine perforation.

1.1 PRESSURE CALIBRATION 1.1.1

Equipment List

The following equipment list or equivalent is needed to perform the procedure: 1. Pressure meter: DigiMano model DPM 2000PS. NETECH Corporation, 60 Bethpage Drive, Hicksville, NY 11801, Telephone: (800) 547-6557/ (Any calibrated NBS traceable pressure gauge with a range of at least +6 psi can be used). 2. Syringe: PN 3099650, Becton-Dickinson, McKesson General Medical, 4501 Pell Drive, Sacramento, CA 95838, Telephone: (800) 366-8990. 3. Trumpet valve: PN S5402601, Braun Medical, Inc., 824 Twelfth Ave., PO Box 027, Bethlehem, PA 18018-0027, Telephone: (800) 227-2862. 4. T connector: PN T20-1, Value Plastics, Inc., 3350 Eastbrook Dr., Fort Collins, CO 80525, Telephone: (970) 223-8306. 5. Tubing: 0.093 ID, 0.156 OD, Norton Performance Plastics Corp, PO Box 660, Akron, OH 44309-3660, Telephone: (800) 798-1539. 6. Male luer lock adapter: PN B0850402, Braun Medical, Inc., 824 Twelfth Ave., PO Box 4027, Bethlehem, PA 18018-0027, Telephone: (800) 227-2862. Diagram 6

~~~:!~~: ( [25I1J

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Syringe

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@

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-~ -----

-Male luer lock adapter

Trumpet valve

Page 6

c==J c==J

I··..·---·..·" ~ ..-~,-, I-"-~' "'-,~." 11

LT~Connector

GYNECARE THERMACHOICE UBT System Operating Manual

Pressure gauge

Page 31

EMC Tables Recommended Separation Distances between Portable and Mobile RF Communications Egui£ment and the GYNECARE THERMACHOICE UHT system The GYNECARE THERMACHOICE UBT system is intended for use in an electromagnetic enviromnent in which radiated RP disturbances are controlled. 111e customer or the user of the GYNECARE THERMACHOICE UBT system can help prevent electromagnetic interference by maintaining il minimum distilnce between portable and mobile RP communications equipment (tTilnsmitters) and the GYNECARE THERMACHOICE UBT system as recommended below, according to the lnaxlll1u111 output power of the comn1unications equipment. Rated Maximum Output Power of Transmitter

Separation Distance According to Frequency of Transmitter m

W 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d ~ [3.5/V, JJP

d ~ [3.5/E,IJP

d ~ [7/Ed'rp

om

0.12

0.12

0.1

0.37

0.37

1

1.17

1.17

2.33

10

3.69

3.69

7.38

100

11.67

11.67

23.33

"

0.23 0.74

For transmitters rated at a maximum output power not listed ilbove, the recommended separation distance d in meters (m) can be estimated using U,e equation applicable to the frequency of the transmitter, where P is the ITlaxilnurn output power rating of U1e trE1I1smilter in watts (,V) according to the transmitter manufacturer. "'aTE 1: At 80 MHz and 800 MHz, U1e separation distance for Uw higher frequency rilnge applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects ilnd people.

Page 30

1. If the catheter can be inserted to a greater depth than was determined by the uterine sound 2. If the pressure cannot be stabilized at 160 - 180 mmHg with up to 35 ml* of fluid 3. If the pressure drops quickly at any point during the procedure *35 ml of fluid in the THERMJ1CHOICE III device is approximately equal to the 30 ml used

in the THERMACHOICE I clinical study. • If a perforation is suspected, THE PROCEDURE SHOULD BE TERIvllNATED IMMEDIATELY. The physician may elect to perform a diagnostic procedure to confirm perforation. If the physician cannot absolutely rule out perforation, the procedure should be abandoned. • 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. • If a perforation is present, and the procedure is not terminated, thermal injury to adjacent tissue may occur if the heater is activated. • After completing the procedure it is important not to touch the GYNECARE THERMACHOTCE Uterine Balloon for the following reasons: - The balloon is covered with blood and body fluids - There are mechanical and electrical parts that could puncture the balloon • Proper care should be taken in disposing of the catheter.

PRECAUTIONS • The GYNECARE THERMACHOlCE III UBT catheter, controller, and umbilical cable are designed as a system. To ensure proper function, never use other components with the GYNECARE THEIDvlACHOICE L13T System. • A starting pressure of 160 - 180 mmHg is recommended and typically requires 6 - 15 ml of fluid and may require as much as 35 ml for the THERMACHOlCE TIT catheter and 30 ml for the THERMACHOICE I catheter. Titration to achieve a stable pressure (no fluctuations greater that ±10 mmHg for at least 30 seconds) prior to activating the heating element is critical to proper functioning of the device. When inserting fluid, do not exceed a pressure of 200 mmHg. Typically, pressure levels decline slowly during the course of the procedure as the uterus relaxes. If a pressure of 160 - 180 mrnHg cannot be reached with up to 35 ml or less of fluid for the THERMACHOICE HI catheter and 30 ml for the THER.c,1ACHOICE I catheter, or if there is a rapid drop in pressure, it is likely there is a uterine perforation. • Rapid loss of pressure during a therapy cycle may indicate a uterine wall defect. Adding additional fluid to the balloon may create (or exacerbate if already present) a uterine wall defect such as a perforation. • Those patients who have undergone endometrial ablation and are later placed on hormone replacement therapy should have progestin included in their regimen in order to avoid the increased risk of endometrial adenocarcinoma associated with unopposed estrogen replacement therapy. • Never add additional fluid during a therapy cycle. • The safety and effectiveness of the GYNECARE THERMACHOICE UBT System has not been fully evaluated in patients: - with large uterine cavities (>35 ml* in volume or uterine sound>12 cm)

GYNECARE THERMACHOICE UBT System Operating Manual

Page 7

- with small uterine cavities «2 ml in volume or uterine sound <4 cm) - with submucosal myomas, bicornuate or septate uteri or previous endometrial resection/ ablation - undergoing repeat endometrial ablation procedures - who are post-menopausal *35 ml of fluid in the THERMACHOICE III device is approximately equal to the 30 1111

used in theTHERMACHOICE I clinical study. • It has been reported that patients with a severe anteverted retroflexed or laterally displaced uterus are at an increased risk of uterine wall perforation during any intrauterine manipulation. The clinician should use discretion in patient selection. • 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 insure that the device is properly positioned in the uterine cavity.

EMC Tables Guidance and Manufacturer's Declaration - Electromagnetic Immunity The GYNECARE THERMACHOICE UBT system is intended for use in the electromagnetic environment specified below. The customer or the user of the GYNECARE THERMACHOICE UBT system should assure that it is used in such an environment. lEC 60601 Test Level

Compliance Level

I Electromagnetic Environment - Guidance

Conducted RF IEC 61000-4-6

3Vrms 150 kHz to 80 MHz

3V

Radiated RF

3VrnlS 80 MEz to 2.5 GHz

3 Vim

Portable and mobile RF communicatiOllS equipment should be used no closer to any part of the GYNECARE THERMACHOICE UBT system, including cilbles, than the recommended separation distance calculated from the equation applicable to the frequency of

Immunity Test

IEC 61000-4-3

the transnritter.

ADVERSE EVENTS CLINICAL STUDY In a study of 134 women performed with a previous generation balloon catheter (version 1.2) [without the fluid circulation mechanism inside the balloon]' the most frequent events that have been reported following completion of the procedure include:

•

•

•

• •

•

Cramping/pelvic pain - Post-treatment cramping was reported in 91.8% of the patients which ranged from mild to severe as reported during the intra-operative and immediate post-operative period. This cramping will typically last a few hours and rarely continues beyond the first day following ablation. The use of non-steroidal anti-inflammatory drugs (NSAIDs) prior to and following UBT is usually sufficient to manage cramping and pelvic pain. Nausea and Vomiting - Nausea and vomiting were reported for 23.9% of the patients in the immediate hours following the procedure. This may be attributed to general anesthesia, and can be easily managed with medication. Endometritis was reported in 2.1 % of patients. All patients responded to a course of oral antibiotics. Post-procedure symptoms such as pain, fever, nausea, vomiting, difficulty with defecation or micturition were reported. Failure of such symptoms to resolve over a reasonable period of time warrants evaluation by appropriate medical personnel. Pregnancy was reported in one patient (0.8%) resulting in a 2-month premature live infant. Pregnancy following endometrial ablation is dangerous to both mother and fetus. Hematometra was reported in 0.6% of patients treated in clinical studies conducted outside of the United States. In all patients, the hematometra was resolved with insertion of a uterine sound. A single perforation of the uterus was reported in a controlled clinical study.

OTHER ADVERSE EFFECTS As with all endometrial ablation procedures, serious injury or death can occur. The following adverse effects might be potentially expected or have been reported in association with the use of the GYNECARE THERMACHOICE UBT System:

Recommended Separation Distance d = [1.17J ,;p

d = [1.17J /p

80 MHz to 800 MHz

d = [2.33] ,;p

800 MHz to 2.5 GHz

'where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recOlnmended separation distance in metres (m). Field strengths from fixed RP transmitters, as determined by an electromagnetic site survey,' should be less than the compliance level in eilch frequency range.' Interference may occur in the vicinity of equipment marked "~th the follO,,~ng symbol:

((<e))) I

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular I cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theore tically with accuracy. Tb assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the GYNECARE THERMACHOICE UBT system is used exceeds the applicable RF compliance level above, the GYlTECARE THERMACHOICE UBT system should be observed to verify normal operiltion. If abnorn1a1 performance is observed, additional measures may be necessary, such as reorienting or re10cating the GYNECARE THERMACHOICE UBT system. " Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 Vim.

1. Rupture of the Uterus

Page 8

GYNECARE THERMACHOICE II System Operating Manual

Page 29

EMCTables Guidance and Manufacturer's Declaration - Electromagnetic Immuni!}: The GYNECARE TIIERMACHOrCE VET system is intended for use in the clecbumagnetic emironmcnt specified below. The customer or the user of the GYNECARE THERMACHOICE VET system should assure that it is used in such an environment. Immunity Test

lEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance I

Electrostatic Discharge (ESD) IEC 61000-4-2

±6 kV Contact

±6 kV Contact

±8kVAir

±8 kV Air

Floors should be wood, concrete or ccranlic tile. If floors are covered "vith synthetic material, the relalive humidity should be at least 30%.

Elecbical Fast Transient / Burst lEC 61000-4-4

±2 kV for Power Supply Lines

±2 kV for Power Supply Lines

±1 kV for Input / Output lines

±1 kV for Input / Output lines

±1 kV Differential Mode

±1 kV Differential Mode

±2 kV Common Mode

±2 kV Common Mode

<5%UT (>95 % Dip in UT) for 0.5 Cycle

<5% UT (>95 % Dip in UT) for 0,5 Cycle

40 (ie LiT (60 '7< Dip in UT) for 5 Cvcle

4O%UT (60 % Dip in U r) for 5 Cycle

70% UT (30 % Dip in UT) for 25 Cycle

70% UT (30 % Dip in UT) for 25 Cycle

<5 S;, U/ (>95 Ch Dip in UJ ) for .5 sec

<5%UT (>95 % Dip in UT) for 3 sec

3A/m

3A/m

Surge lEC 61000-4-5

Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input Lines lEC 61000-4-11

Power Frequency (50/60 Hz) Magnetic field lEC 61000-4-8

Mains power quality should be that of a typical commercial or hospital envirorunent.

Mains power quality should be that of a typical commercial or hospital erniromnent. Mains power quality should be that of a typical commercial or hospital environment. If the user of the GYl1iCARE THERMACHOICE VET systenl requires continued operation during pO,7er mains interruptions, it is recommended that the GY~1iCARE THERMACHOICE VET system be powered from an unintenuptible power supply or a battery.

Power frequency maS'11etic fields should be at levels characteristic of a typical location in a typical commercial or hospital envirolUnent.

NOTI: UT is the a.c. mains voltage prior to application of the test level.

2. Thermal Injury to Adjacent Tissue 3. Heated Liquid Escaping Into the Vascular Spaces and/or Cervix, Vagina, Fallopian Tubes, and Abdominal Cavity 4. Electrical Burn 5. Hemorrhage

6. Infection or Sepsis 7. Perforation 8. Post-ablation-tubal sterilization syndrome - This is a complication following endometrial ablation in women who have also previously undergone tuballigation. The pathophysiology of this condition is believed to be related to the regeneration of endometrium in the cornual areas of the uterus. Blood from these glands can flow back into the proximal fallopian tubes in cases where the lower uterine segment is extensively scarred. The proximal oviduct becomes filled with blood and fluid causing symptoms similar to those of an ectopic pregnancy. 9. Complications leading to serious injury or death.

CLINICAL TRIAL The CYNECARE THERMACHOICE mc catheter (version 3.0) and CYNECAIZE THERMACHOICE nc catheter (version 2.0) includes an active mechanism for circulation of the DsW within the balloon. The CYNECARE THERMACHOICE catheter (version 1.2) has a passive circulation which is based on convection. The clinical data presented below were obtained using the previous generation non­ circulating balloon catheter, however, laboratory testing (ex-vivo experiments conducted on extirpated human uteri) has shown that the active circulation of fluid within the balloon will lead to a more even distribution of heat at the balloon surface, and thereby over the endometrial tissue. Conclusions: In a study performed with a previous generation balloon catheter (version 1.2) [without the fluid circulation mechanism inside the balloon] at twelve, twenty-four, and thirty-six months of follow-up, balloon ablation was demonstrated to be at least as safe (with fewer intra-operative complications and shorter procedure times), and as effective as hysteroscopic rollerball ablation in reducing menstrual bleeding to a clinically acceptable level in menorrhagic women who had completed their childbearing. Furthermore, statistically equivalent and significant reductions in patient-reported dysmenorrhea (mild, moderate, severe menstrual cramps), PMS symptoms (mild, moderate, severe common PMS symptoms), and overall impact of menses on lifestyle (scale of 1-10; l=none, lO=severe) were experienced by both groups. Purpose: The use of balloon thermal ablation for the treatment of menorrhagia for benign causes in an anatomically normal uterine cavity was compared with rollerball electrosurgical endometrial ablation with regard to safety and effectiveness. The primary effectiveness measure was a validated dimy scoring system (adapted from Higham JM, O'Brien PMS, Shaw RW, Assessment of menstrual blood loss using a pictorial chart, Br J Obstet GynaecoI1990;97:734-9l. Success was defined as the reduction of excessive menstrual bleeding to normal flow or less. Secondary endpoints evaluated were overall percent decrease in diary scores and responses from a quality­ of-life questionnaire. The endpoints for safety were based on the evaluation of adverse events associated with each procedure, including device-related complications, time of procedure, and type of anesthesia use.

Page 28

CYNECARE THERMACHOTCE UBT System Operating Manual

Page 9

Methods: This randomized, prospective, multicenter clinical investigation obtained using the previous generation non-circulating balloon catheter was conducted at 14 sites using investigators highly experienced with hysteroscopic rollerball endometrial ablation. All patients were >30 years old, premenopausal, and had completed childbearing. All had an anatomically normal uterine cavity >4 cm and <10 cm. Three months of documented menorrhagia for benign causes was a requirement for inclusion and was confirmed with a diary score of at least 150 points. Endometrial biopsy and pap smear were required to rule out (pre)malignant uterine disease. No uterine thinning medications could be used for three months prior to treatment, and all patients underwent a three-minute suction curettage just prior to treatment. Selection of anesthesia regimen was left to the individual investigators. Treatment success was defined as reduction in menses to a diary score less than or equal to 75 in order to assure a return to eumenorrhea. In the original Higham study, a diary score of 100 had an 86% sensitivity and an 81 % specificity for true menorrhagia for benign causes as determined by chemical analysis of the saturated pads.

PATIENT POPULATION •

•

260 patients in Safety Evaluation Group 034 TC; 126 RB) - 1 aborted RB for uterine perforation - 2 aborted (1 TC; 1 RB) for submucous fibroid - 2 aborted TC for inability to maintain device pressure 255 patients treated with test or control device (131 TC; 124 RB)

EMC Tables Guidance and Manufacturer's Declaration - Electromagnetic Emissions I The GYNECARE THERMACHOrCE UBT system is intended for use in the electromagnetic enviromnent specified below. The customer or the user of the G'{NECARE THERL'v1ACHOICE , UBT system should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions Group 1 The GYNECARE THERMACHOlCE CISPR 11 UBT system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF Emissions Class A The GYf'.J'ECARE THERMACHOlCE UBT crSPR 11 system is suitable for use in all e~tablishrnents other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes. Harmonic Emissions Class A lEC 61000-3-2 Voltage Fluctuations / Flicker Complies Emissions IEC 61000-3-3

Baseline demographic, physical exam and gynecological variables were statistically equivalent between the test and control groups with regard to age (TC 40.2 years, RB 40.9 years), race, body mass index, mean baseline diary score (TC 552.5, RB 570) and other parameters.

Page 10

GYNECARE THERMACHOICE UBT System Operating Manual

Page 27

ENVIRONMENTAL CONDITIONS Transport and Storage Ambient temperature ...-20 to +50°C Relative humidity ...20% to 85% non-condensing Operation Ambient temperature ... 10 - 40°C Relative humidity ...20% to 85% non-condensing Electromagnetic Compatibility ESD ...Direct & Indirect: Conforms to IEC 60601-1-2 EMI .. ... ... Conforms to IEC 60601-1-2 Leakage Currents Patient Leakage Current .. ...Conforms to IEC 60601-1 Earth Leakage Current ...Conforms to IEC 60601-1

Subject Withdrawals - Table la Subjects: Entered into study (Intent to Treat Population)

GYNECARE THERMACHOICE

ROLLERBALL

134

126

Procedure aborted

3

2

Receiving complete treatment

131

124

For whom 12-month data not available:

6

10

2 1

4

Hysterectomy Withdrew

- 1 daughter's death - 1 menorrhagia - ] depression

ELECTROMAGNETIC INTERFERENCE • Medical electrical equipment needs special precautions regarding EMC and the GYNECARE THERMACHOICE II UBT system needs to be installed and put into service according to the EMC information provided below: • Portable and mobile RF communications equipment can interfere with the GYNECARE THERMACHOICE II UBT system's operation. • Stacking or placing the GYNECARE THERMACHOICE II UBT system adjacent to other devices is not recommended. Where such configurations are necessary, all equipment should be carefully monitored to ensure that Electromagnetic Interference (EM!) does not degrade performance. • In general, sensitive electronic equipment should always be positioned as far away as possible from sources of high frequency voltages and currents, such as electro-surgical generators. Moreover, cables connected to high frequency sources should be kept as short as possible and must never be routed near or parallel to cables of sensitive equipment. • The use of cables, transducers, and accessories other than those specified by GYNECARE in this operator's manual may result in increased emissions or decreased immunity of the GYNECARE THERMACHOICE UBT system.

3

- 1 amenorrhea @ 3 moo

.'

Lost to follow-up

3 - 1 diary score 14 - ] amenorrhea @ 3 moo

3 - 1 amenorrhea @ 3 moo - 1 6-mo. diary score 32 - 1 6-mo. diary score 77

For whom 12-month data available:

125

114

For whom 24-month data not available: Hysterectomy Lost to follow-up

3 2 1

9 6

3

- 1 yr. hypomenorrhea

For whom 24-month data available: For whom 36-month data not available: Repeat Ablation Hysterectomy Lost to follow-up

122

105

8

1 4

5

2 - both hypomenonhea @ 2 yr.

Withdrew For whom 36-month data available:

Page 26

1

114

GYNECARE THERMACHOICE UBT System Operating Manual

100

Page 11

RESULTS

EFFECTIVENESS Table lb. Effectiveness Bleeding Rates shows the success rates for the Intent to Treat Group (134 TC; 126 RB) as based on diary scores at the 1-year follow-up of 75 or less. Success at 24 and 36 months, based on telephone questionnaires, is defined as elimination of bleeding or reduction to light or normal flow. The worst-case scenario is presented whereby each of the discontinued patients (described below in the footnotes) is counted as a "failure" for calculating the values listed in the table. Only the amenorrhea rate at 1 year is statistically significantly different between treatment groups (P ::;; 0.05).

GYNECARE THERMACHOICE UET

ROLLER EAU

12'

Number of Successful Patients Study Success Rate

24'

SERVICING / EQUIPMENT DISPOSAL

n=126

n=134 Months Post Treatment

36"

12'

24"

36'

101

109

106

97

95

94

75.4%*

81.3%*

79.1%*

77.0%*

75.4%*

74.6%*

19

16

17

31

23

27

11.9%*

12.7%*

24.6%*

18.2%*

21.4%*

# of Patients with Amenorrhea (# Patients with diary scores = 0)

Amenorrhea Rate (% Patients with diary scores = 0) ·14.2%** a - based on diary scores b - based on telephone questiOlmaires *Not Statistically Significant (P> (J.OS) **Statistically Significant (P ,,; O.()S) fSee Table la for Subject Withdrawals

GYNECARE shall in no e'ent be liable for any special, indirect or consequential damages of any kind and howe'er caused arising from the sale or use of the UBT system. Should any GYNECARE controller become inoperable after the one year period of this Warranty or should damage occur which is not covered under the terms of this Warranty, GYNECARE will, upon request, repair the controller, if possible, for an appropriate handling and repair charge.

Table lb. Effectiveness Bleeding Rates Intention to Treat Groupt

..

ACCESSORIES OR PARTS USED IN CONJUNCTION WITH THE GYNECARE CONTROLLER AND NOT SUPPLIED AND MANUFACTURED OR INSTALLED BY GYNECARE THE TERM "ORIGINAL PURCHASER", AS USED IN THE WARRANTY, SHALL BE DEEMED TO MEAN THAT PERSON OR ORGANIZATION AND ITS EMPLOYEES, IF APPLICABLE, TO WHOM THE GYNECARE CONTROLLER WAS SOLD BY GYNECARE THIS WARRANTY MAY NOT BE ASSIGNED OR TRANSFERRED IN ANY MANNER.

Should the GYNECARE THERMACHOICE UBT System controller become inoperable, contact your local sales representative. Clean and repackage the controller appropriately and return it for repair, servicing and/ or modification to JaBil Global Services Inc., 11201 Electron Drive, Louisville, KY 40299 (US customers only) or your local GYNECARE authorized service center. If the controller is not under warranty, an appropriate handling and repair charge will be established after receipt and examination of the controller. Note: The GYNECARE THERMACHOICE UBT System controller contains electronic printed circuit assemblies. At the end of the useful life of the equipment, it should be disposed of in accordance to any applicable national or institution related policy relating to obsolete electronic equipment. Note: Dispose of any system accessories according to normal institution practice relating to potentially contaminated items. Note: Any device related incident or problems which are felt to represent a safety issue should be reported by calling GYNECARE at 1-877-ETHICON.

ORDERING INFORMATION For ordering information call 800-255-2500.

SPECIFICATIONS (CONTROLLER & UMBILICAL CABLE) POWER SOURCE (Controller) Power Requirements ... 100 to 240 VAC; 50/60 Hz; 110 watts; 3-wire grounded system Regulation Voltage ...90 to 264 VAC, 47-63 Hz, single phase Mains Fuses ... 250 VAC, 5 x 20 mm 1.6 A standard MECHANICAL CHARACTERISTICS Dimensions ... Height 10.2 cm (4 in.), width 41.2 cm (16.25 in.), depth 37.0 cm 04.56 in.) Weight ... 6.9 kg (15.3 Ibs) (controller only) Case ... Aluminum and impact-resistant plastic Umbilical Cable ... Length 152 cm (60 in.) Page 12

GYNECARE THERMACHOICE UBT System Operating Manual

Page 25

Table le. Effectiveness Quality of Life presents the quality of Life Questionnaire responses for patients who responded at 12, 24 and 36 months. Patients discontinued prior to the visit (described in Table la) were not included in the calculations. There were no statistically significant differences between groups. Table le. Effectiveness Quality of Life t

Prior to pressing START ( <J> ) - The following error messages indicate conditions under which the controller will not begin therapy cycle until corrected: MESSAGE DISPLAY

REASON

ACTION

CONNECT CATHETER

Balloon catheter and/or umbilical

Connect balloon catheter. Ensure connections are secure. Once connected, if message persists,replace catheter and / or umbilical cable.

CATHETER ERROR REPLACE CATHETER

Balloon catheter and/ or umbilical cable is not functioning properly.

Replace balloon catheter and/ or umbilical cable.

SYSTEM ERROR TURN POWER OFF

System is not functioning properly.

Return controller for repair. - ­

After pressing START ( <J> ) - The following error messages indicate conditions under which' the controller will terminate the procedure and disable the heating element after the therapy cycle has begun: MESSAGE DISPLAY CATHETER ERROR END PROCEDURE

REASON Balloon catheter is not functioning properly.

ACTION Remove fluid. Remove balloon catheter.

SYSTEM ERROR or HEATER ERROR and END PROCEDURE

System is not functioning properly.

Remove fluid. Remove balloon catheter. Return controller for repair.

PREHEAT ERROR or OVERHEAT ERROR or UNDERHEAT ERROR or PRESSURE ERROR and END PROCEDURE

Treatment temperature and/or pressure is outside standard operating parameters.

Remove fluid. Remove balloon catheter.

GYNECARE THERMACHOICE UBT

I

Months Post Ablation

ROLLERBALL

12

24

36

12

24

36

# of Patients Who Responded to

Quality of Life Questionnaire % Patients with anemia pre-treatment (HCT)

125

122

114

114

105

100

79.9%

N/A

N/A

29.7%

N/A

N/A

% Patients with anemia post-treatment (HCT)

11.6%

N/A

N/A

10.6%

N/A

N/A

Satisfaction: very satisfied or satisfied

96.0%

95.9%

95.6%

98.2%

98.1%

97.0%

% Patients with reduction in dysmenorrhea

70.4%

72.1%

73.7%

75.4%

75.2%

78.0%

% Patients unable to work outside the home pre-treatment

39.7%

39.7%

39.7%

41.9%

41.9%

41.9%

% Patients unable to work outside the home post-treatment

4.0%

0.8%

2.7%

2.7%

2.9%

1.0%

70.3%

70.3%

70.3%

78.6%

78.6%

78.6%

3.2%

4.9%

1.8%

1.8%

1.0%

2.0%

% Patients reporting severe impact on life pre-treahnent % Patients reporting severe impact on life post-treatment

tSee Table la for Subject Withdrawals

WARRANTY

SAFETY

GYNECARE, a Division of ETHIC ON, INC., warrants to the original purchaser of the GYNECARE THERMACHOICE UBT System Controller that it shall be free of defects in material and workmanship when used as intended under normal surgical conditions and in conformance with its directions for use and maintenance instructions. The obligation of GYNECARE under this warranty shall be limited to the repair or replacement, each at no charge, at the option of GYNECARE within one year from the date of purchase, if examination shall disclose to the satisfaction of GYNECARE that the controller does not meet this warranty.

Table H. Safety shows there were no intra-operative adverse events and 4 post­ operative adverse events in the GYNECARE THERMACHOICE UBT Group (n=134). In the Rollerball Group (n=126) there were 4 intra-operative adverse events and 3 adverse events in the immediate post-operative period. These differences were not statistically significant. The mean procedure time for the TC patients was statistically significantly less than for the RB patients.

THIS WARRANTY IS MADE IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR USE AND ALL OTHER OBLIGATIONS AND LIABILITIES ON THE PART OF GYNECARE. GYNECARE NEITHER ASSUMES NOR AUTHORIZES ANY OTHER PERSON TO ASSUME FOR IT, ANY OTHER LIABILITY IN CONNECTION WITH THE SALE OF A GYNECARE CONTROLLER. THIS WARRANTY SHALL NOT APPLY TO A GYNECARE CONTROLLER OR ANY PART THEREOF WHICH HAS BEEN SUBJECT TO ACCIDENT, NEGLIGENCE, ALTERATION, ABUSE, OR MISUSE, NOR TO ANY GYNECARE CONTROLLER THAT HAS BEEN REPAIRED OR ALTERED BY ANYONE OTHER THAN AN AUTHORIZED GYNECARE SERVICE PERSON. GYNECARE MAKES NO WARRANTY WHATSOEVER WITH REGARD TO

Table H. Safety GYNECARE THERMACHOICE UBTn=134 Intra-operative adverse events

None

ROLLERBALL n=126

(0 %)

2 fluid overload 1 cervical laceration 1 uterine perforation

1 post-coital bleeding 3 endometritis 1 UTI (3.7%)'

1 endometritis 1 hematometra 1 PATSSl (2.4%)'

(3.2%)

Post-operative adverse events

Mean procedure time (minutes) Procedure time is duration between 27.4*' patient prep and catheter removal 1 PATSS = post-ablation-tubal sterilization syndrome

39.6**

*Not Statistically Significant (P> 0.05) *:i-Statistically -Significant (PS 0.05)

Page 24

GYNECARE THERMACHOICE UBT System Operating Manual

Page 13

ANESTHESIA REGIMEN Selection of anesthesia regimen was left to the individual investigators. Fewer cases were performed under general anesthesia in the GYNECARE THERMACHOICE UBT group as compared to the Rollerball group. For GYNECARE THERMACHOICE UBT only 53.7% had the procedure under general anesthesia versus 84.1 % who had the Rollerball procedure performed using general anesthesia.

failure, the procedure will be terminated. If the procedure is terminated, the Message Display will display a message indicating the cause. The following chart explains operating parameters for temperature, time, and pressure: Standard Temperature 87°e

Alarm / Heater Over

Range 75-90 o e

HYSTERECTOMY There were a total of 22 patients (8 TC; 14 RB) who had a hysterectomy within 3 years after endometrial ablation. Table Ill. Hysterectomy Reason for Hysterectomv Possible Carcinoma (found negative) Menorrhagia / abnormal bleeding Pelvic pain/severe dysmenorrhea Endometriosis / ovarian cysts Total

Total* Te (n=134) RB (n=126) 0

3 4 1

8 (8.6%)

1 5 6 2 14 (11.1%)

. Under

Pressure

70-21OmmHg

Titrate to 160-180 mmHg before starting procedure; activation pressure (minimum starting Eressure) >150 mmHg Time

Shut-off Limits .:o:95°e for 2 seconds or between 90-94°e for 15 seconds ::;:75°e for 15 seconds*

Over

.:0:210 mmHg for 2 seconds

Under

:::;70mmHgfor 2 seconds

Over

>4 minute pre-heat

.'

8-minute therapy cycle after reaching 87°e (preheat phase)

'13 hysterectomies were in patients <40 years (4 rc, 9 RB); 9 hysterectomies were in patients >40 years (4 rc, 5 RB)

PATIENT SELECTION

'or failure to achieve temperature of 87' C within 4-minute preheat phase

Menorrhagia can be caused by a variety of underlying problems including but not limited to, endometrial cancer, myomas, polyps, anovulation, drugs, and dysfunctional uterine bleeding. Patients should always be evaluated to determine the cause of their excessive uterine bleeding before any treatment option is initiated.

When parameters extend outside the normal operating range, the controller sounds an audible alarm (intended only as a warning signal to the clinician). These values are listed below and reside between normal operating parameters (see previous chart):

Consult medical literature relative to various endometrial ablation techniques, indications, contraindications, complications, and hazards prior to the performance of any endometrial ablation procedures.

Temperature Pressure

The patient selection criteria are: • • • • •

• •

Documented diagnosis of menorrhagia for benign causes Completed childbearing Premenopausal Normal pap smear and endometrial biopsy Anatomically normal uterine cavity: standard sonography, saline infusion sonography, hysteroscopy, or hysterosalpingography within 6 months prior to performing GYNECARE THERMACHOICE UBT should be used to rule out submucous fibroids, large polyps, and congenital abnormalities Uterine cavity depth of 4-12 cm Failed or contraindicated medical therapy

Over Under Over Under

Alert (Warning) >90 oe & <95°e for 2 seconds <83°e for 2 seconds >200 mmHg & <210 mmHg for 2 seconds >70 mmHg & <100 mmHg for 2 seconds

ERROR MESSAGES Under electrostatic discharge to the controller or abnormal line voltage conditions, i.e., surge and fast transients, the system may reset to the initial power-up state. It is also possible that the unit may tenninate the procedure with an error code. In this case, turn off the power to the controller and restart the procedure. In addition to the operating messages listed in the "Directions," the message Display also provides messages which indicate conditions under which the controller either will not begin treatment or will terminate treatment after the heating cycle has been initiated.

PATIENT COUNSELING As with any procedure the physician needs to discuss risks, benefits and alternatives with the patient prior to performing endometrial ablation. In addition, the physician should discuss signs and symptoms of potential complications such as bleeding, infection or thermal injury. Page 14

GYNECARE THERMACHOICE UBT System Operating Manual

Page 23

Note: Never add additional fluid during a therapy cycle as this could create (or excerbate if already present) a uterine wall defect such as a perforation. 4.4 When the treatment cycle is completed, the Message Display will alternate

between the following messages: THERAPY COMPLETED

and

COOLING DOWN PLEASE WAIT

4.5 The controller automatically terminates the heater at the end of the treatment (cycle) and an audible alarm will sound.

The device is intended for use only in women who do not desire to bear children because the likelihood of pregnancy is significantly decreased following this procedure. Post-procedure pregnancy may be dangerous for both mother and fetus. Patients of childbearing capacity should be counseled that endometrial ablation is not a sterilization procedure and should be provided an appropriate birth control method. Patients with childbearing capacity should be cautioned of the potential complications which may ensue if they should become pregnant. Vaginal discharge is typically experienced during the first few days following ablation and may last as long as a few weeks. Generally, the discharge is described as bloody during the first few days; serosanguinous by approximately one week; then profuse and watery thereafter.

5.0 POST-TREATMENT

PRETREATMENT PREPARATION OF PATIENT

5.1 The cool down cycle takes 30 seconds. When the cycle is completed, the Message Display will read the fC!lloWing:

The lining of the uterus should be thinned prior to GYNECARE THERMACHOICE UBT. This can be accomplished by timing the menstrual cycle to the early proliferative phase, administering pretreatment drugs such as danocrine or GnRH agonists, or performing suction or sharp curettage immediately prior to performing the endometrial ablation. The optimum pretreatment regimes have not been determined at this time.

THERAPY & COOL DOWN COMPLETED

then

REMOVE FLUID REMOVE CATHETER

Remove fluid by drawing back on syringe while depressing trumpet valve. Remove all fluid from balloon. Remove the balloon catheter. Check that the entire fluid volume is withdrawn.

It is recommended that a non-steroidal anti-inflammatory drug (NSAID) be given at least one hour prior to treatment and continued post-operatively as necessary to reduce intra-operative and post-operative uterine cramping.

5.2 Disconnect the catheter pressure line from the controller.

5.3 Disconnect the circulation catheter plug, if applicable, from the controller.

DIRECTIONS FOR USE

5.4 Disconnect the umbilical cable from the catheter (for version 1.2) or from the catheter umbilical cable connection (for versions 3.0 and 2.0) by pulling back the gray collar.

Please read all directions, precautions and warnings prior to use.

5.5 Disconnect the umbilical cable from the controller by holding the stainless steel ribbed shell and pulling back. Do not pull on the cable itself. 5.6 Discard the catheter. Retain the umbilical cable and disinfect for the next case. 5.7 Power must be turned off before beginning another procedure. Note: When a controller is left on without use for 8 hours, the controller freezes and displays the following message: MAX TIME EXPIRED TeRN POWER OFF

OPERATING PARAMETERS / ALARM AND DISPLAY MESSAGES

1.0 SET-UP

1.1 The following items are required for use of the GYNECARE THERMACHOICE UBT System. GYNECARE THERMACHOICE UBT System • 1 sterile disposable balloon catheter (see catheter version matrix below) and syringe (30 mll • 1 umbilical cable • 1 controller • 1 power cord Catheter Version 3.0

Circul~tion catheter

Silicone balloon

Catheter Version 2.0

Circulation catheter

Silicone balloon

Catheter Version 1.2

Non-circulation catheter

Latex balloon

The controller is designed to monitor time, temperature and pressure within parameters present at the factory. • •

ALERT. If the temperature and / or pressure increases or falls beyond a level preset at the factory, the controller will sound a short audible alarm. HAZARD ALARM/TERMINATION OF PROCEDURE (HEATER SHUT OFF LIMITS). If the temperature and/or pressure increase or falls outside the operating parameters, the controller will sound an alarm, terminate the procedure and display an error message. Additionally, if the controller detects a system

Page 22

Has fluid circulation

mechanism inside the balloon Has fluid circulation mechanism inside the balloon Does not have fluid circulation mechanism -­

GYNECARE THERMACHOICE UBT Svstem Overatinz Manual

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Paze 15

Medical Supplies • 50 ml sterile injectable plain 5% dextrose in water (DsW) • tenaculum (weighted) speculum • uterine sound, cervical dilator(s) • sterile drape for umbilical cord (optional) Note: Use only plain DsW to inflate balloon catheter - never use any other fluid. 1.2 Open the sterile package containing the GYNECARE THERMACHOICE UBT Catheter and Syringe. Disinfect umbilical cable as described at the end of this manual. Handle balloon portion of the catheter carefully to prevent damage. 1.3 Make sure that the controller power is off before making the connection (Steps 1.4 - 1.6). 1.4 Plug the power cord into the back of the controller and into the wall outlet. 1.5 The umbilical cable includes a connector plug at each end to connect the balloon catheter to the controller. Visually inspect the cable and connector plugs to ensure there are no defects or signs of wear. Drape umbilical cable with sterile drape, if necessary, and attach cable to the connector on the catheter umbilical cable connection (for catheters version 3.0 and 2.0) or at the end of the balloon catheter for version 1.2 (match arrows on umbilical cable to notch on catheter). Attach the opposite end of the cable to the connection port on the front panel of controller. (Align red dots from umbilical cable to controller). (See Diagram 4 for circulation catheter versions 3.0 and 2.0 and Diagram 5 for non-circulation catheter version 1.2).

4.0 TREATMENT 4.1 Message Display (alternating):

READY PRESS START

and STABILIZE START PRESSURE>150 When a steady pressure of 160-180 mmHg is maintained, press START (<i» button on controller to activate the heater. Do not add fluid once heater is activated, as this could create (or exacerbate if already present) a uterine wall defect such as perforation. Hold the balloon catheter immobile and centered in the uterine cavity during procedure (with the valve oriented upwards). Failure to hold the balloon catheter immobile during procedure can result in catheter failure. Note: Ensure that the balloon catheter is centered in the uterus to minimize potential overheat error codes during the treatment process. Prior to activating heater. ensure that fluid is on all sides of catheter tip. It is no longer necessary to maintain contact with the fundus. 4.2 After the start button is pressed, the controller activates the heater to achieve treatment temperature of 87°C (188°P) within 4 minutes. (This preheat cycle may take up to 4 minutes for larger uteri, but is usually 15-45 seconds). PREHEATING TO 87°C Note: If the treatment temperature of 87°Cis not reached within 4 minutes, the controller will terminate the procedure. Remove the fluid, remove the catheter. Note: During treatment and in case of emergency, the STOP ( @ ) button can be pressed to terminate the procedure. The stop button will power down the heater and the heater function can only be resumed by turning the unit off and restarting. 4.3 Message Display:

THERAPY CYCLE 87°C, 8 MIN

Once 87°C is reached, an audible tone ,vill indicate the automatic activation of the 8 minute therapy cycle. The Time elapsed will be shown on the "THERAPY TIME" display. After the preheat cycle is completed the time resets to 0:00. The displayed time represents the exact therapy cycle time. Note: Pressure may rise slightly with initial heating. It is common to then see the pressure fall gradually during procedure. If the pressure reaches 200 mmHg, an alarm will sound. If the pressure exceeds 210 mmHg for more than 2 seconds, the controller will terminate the procedure. The procedure may be restarted with a lower starting pressure to complete an 8 minute therapy. Note: A rapid drop in pressure or a failure to maintain pressure may be the result of a catheter leak or uterine perforation. After sufficient cooling, remove the balloon catheter. A work-up for perforation should be considered prior to discharge.

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GYNECARE THERMACHOICE UBT System Operating J1anual

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