Thermachoice II (00825) User Manual
Contents
1. Diagram 6 THERMACHOICE o So oe Oa Syringe Male luer lock adapter Trumpet m T Connector gauge Procedure With no attachments to the luer lock apply power to the controller The pressure display should read 0 10 mmHg 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 While depressing the trumpet valve apply vacuum to the system using the syringe until the gauge reads approximately 250 mmHg Release the trumpet valve The controller pressure reading should be within 10 mmHg of the gauge reading While depressing the trumpet valve apply pressure to the system until the reading on the digital display meter indicates a pressure of approximately 250 mmHg Release the trumpet valve The controller pressure reading should be within 10 mmHg of the gauge reading TEMPERATURE CALIBRATION 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 Connect the catheter to the controller using the umbilical cable as described earlier in the manual Power up the controller Note the thermometer reading and compare to that of the controller The readings should be within 52. Diagram 5 GYNECARE THERMACHOICE Catheter Version 1 2 Match arrows on umbilical cable to notch on catheter Do not remove plug The circulation port is not used for this version of the catheter Controller Align red dots from umbilical cable to controller Pressure line filter Ensure a snug connection Connect the pressure line pre attached to balloon catheter to the connection port luer lock on the front panel of controller Do not overtighten but ensure a snug connection or the device may not function properly See Diagram 4 5 Periodically clean the entrance of the controller s port using a cotton swab with 50 isopropyl alcohol Ensure that the pressure line is fully connected prior to adding any fluid to the system Use this step for the GYNECARE THERMACHOICE IIC and IIIC silicone balloon catheter with fluid circulation version 2 0 and version 3 0 only Remove the plug from the circulation catheter port To remove the plug press on the locking latch and pull the plug Save the plug It should be reinstalled when the controller is not in use Connect the circulation catheter plug into the circulation port It will lock in place with a slight click Make sure it s locked in by slightly pulling on it TURN ON the controller POWER The Message Display will read Message Display Note N NN software revision level REVISION N NN INITIALIZING Message Display CONNECT C
3. Typically pressure levels decline slowly during the course of the procedure as the uterus relaxes If a pressure of 160 180 mmHg cannot be reached with 30 ml or less of fluid 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 gt 30 ml in volume or uterine sound gt 12 cm 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 GYNECARE THERMACHOICE UBT System Operating Manual Page 7 who are post menopausal t has been reported that patients with a severe anteverted retroflexed or laterally displaced uterus are at an increased risk of uterine wall perforatio
4. failure Turn power off to clear error message and replace catheter Possible catheter failure Turn power off to clear error message and replace catheter Return controller to GYNECARE for service Return controller to GYNECARE for service Return controller to GYNECARE for service Possible catheter failure leak Turn power off to clear error Turn power off to clear error Return controller to GYNECARE for service Possible catheter failure Turn power off to clear error message and replace catheter GYNECARE THERMACHOICE II System Operating Manual Page 31 Error Code Table 66 Page 32 UNDERHEAT ERR66XX END PROCEDURE REMOVE FLUID REMOVE CATHETER UNDERHEAT ERR67XX END PROCEDURE REMOVE FLUID REMOVE CATHETER CATHETER ERR68XX END PROCEDURE REMOVE FLUID REMOVE CATHETER Fluid temperature 75 C for 15 seconds Pressure transducer Fluid temperature did not rise 6 C within 30 seconds Return controller to GYNECARE for service Return controller to GYNECARE for service Possible catheter failure Turn power off to and replace catheter clear error message This page has been left blank intentionally GYNECARE THERMACHOICE II System Operating Manual Page 33
5. 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 Rear Panel of Controller Connection port for AC power cord Page 2 DESCRIPTION OF SYMBOLS Front Panel of Controller Off power disconnection from the mains On power connection to the mains Start Button V Stop Button When symbol is illuminated a hazard condition exists which will automatically terminate procedure see ERROR MESSAGES section consult Operator s Manual for further instruction An unilluminated symbol indicates normal operating conditions INSERT CATHETER FILL CATHETER WITH D4W Message Display displays prompts and error messages Displays pressure inside balloon in mmHg Displays heater temperature inside balloon in C Displays total running time for preheat and therapy in MINUTES SECONDS Circulation catheter connection port Rear Panel of Controller See SPECIFICATIONS for additional information Connection port for power cord Pt Location of fuses type and value rating Z lt Equipotentiality Class I Type BF Equipment Cover to be removed by qualified service personnel only Danger Risk of explosion if used in the presence of flammable anesthetics
6. 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 e 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 e 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 e 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 1 Rupture of the Uterus 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 Page 8 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 tubal ligation The pathophysiology of this condition is believed to be related to the regeneration of endometrium in the cornual areas of the uterus Blood
7. Pp CE Mark and identification number of Notified Body Product conforms to the essential requirements of the Medical Devices Directive 93 42 EEC A FN GYNECARE THERMACHOICE UBT System Operating Manual Page 3 Diagram 2 GYNECARE THERMACHOICE IIC Single Use Silicone Balloon Catheter with Fluid Circulation Version 2 0 and Umbilical Cable Depth sound measurement cm Silicone Fluid fill valve Fluid fill port for syringe P nd Trumpet valve Catheter mw Heater cable connection Circulating element Connection Front Panel of Controller Over Poe GLOBE eee relief valve Catheter heater temperature display C Umbilical cable Hazard light Intra balloon Start button Start pressure display button mmHg Message display light C THERMA CHOICE Uterine Balloon Therapy Y Y j CDenessune mmia terenarune 0 TME 0 GYNECAREY ae 0e V a ee ee Total time display Power minutes seconds Stop button switch Connection 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 Rear Panel of Controller opgav E Connection port for AC power cord Page
8. THERMACHOICE UBT System Operating Manual GYNECARE THERMACHOICE ROLLERBALL UBT n 134 n 126 Intra operative adverse events None 2 fluid overload 0 1 cervical laceration 1 uterine perforation 3 2 1 endometritis 1 hematometra 1 UTI 1 PATSS1 3 7 2 4 Mean procedure time minutes Procedure time is duration between patient prep and catheter removal 27 4 39 6 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 HYSTERECTOMY There were a total of 22 patients 8 TC 14 RB who had a hysterectomy within 3 years after endometrial ablation Table III Hysterectomy Reason for Hysterectomy Total TC n 134 RB n 126 Possible Carcinoma found negative 0 1 Menorrhagia abnormal bleeding 3 5 Pelvic pain severe dysmenorrhea 4 6 Endometriosis ovarian cysts 1 2 Total 8 8 6 14 11 1 13 hysterectomies were in patients lt 40 years 4 TC 9 RB 9 hysterectomies were in patients gt 40 years 4 TC 5 RB PATIENT SELECTION Menorrhagia can be caused by a variety of underlying problems including but not limited to endometrial cancer
9. catheter pressure line from the controller Disconnect the circulation catheter plug if applicable from the controller 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 Disconnect the umbilical cable from the controller by holding the stainless steel ribbed shell and pulling back Do not pull on the cable itself Discard the catheter Retain the umbilical cable and disinfect for the next case 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 TURN POWER OFF OPERATING PARAMETERS ALARM AND DISPLAY MESSAGES 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 failure the procedure will be terminated If the procedure is terminated the Message Display will d
10. 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 After the start button is pressed the controller activates the heater to achieve treatment temperature of 87 C 188 F 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 C is 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 Message Display THERAPY CYCLE 87 C 8 MIN Once 87 C is reached an audible tone will 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 mmH
11. 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 GYNECARE THERMACHOICE UBT System Operating Manual Page 23 Prior to pressing START lt gt 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 Balloon catheter and or umbilical Replace balloon catheter REPLACE CATHETER cable is not functioning properly and or umbilical cable SYSTEM ERROR System is not functioning Return controller for repair TURN POWER OFF properly After pressing START 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 REASON ACTION CATHETER ERROR Balloon catheter is not functioning Remove fluid END PROCEDURE properly Remove balloon catheter SYSTEM ERROR or System is not functioning Remove fluid HEATER ERROR and properly Remove balloon cat
12. degrees Celsius GYNECARE THERMACHOICE UBT System Operating Manual Page 27 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 within 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 Mains Fuse Drawer the locking tab Mains Fuse E type and rating 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 3 0 CLEANING CONTROLLER SYSTEM It is good practice to routinely clean the exterior surface of the device 1 Disconnect all umbilical cables and unplug the power cord from t
13. 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 GYNECARE THERMACHOICE IIIC catheter version 3 0 and GYNECARE THERMACHOICE IIC catheter version 2 0 includes an active mechanism for circulation of the DsW within the balloon The GYNECARE 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 com
14. 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 Consult medical literature relative to various endometrial ablation techniques indications contraindications complications and hazards prior to the performance of any endometrial ablation procedures The patient selection criteria are e Documented diagnosis of menorrhagia for benign causes e Completed childbearing e Premenopausal e Normal pap smear and endometrial biopsy e 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 e Uterine cavity depth of 4 12 cm e Failed or contraindicated medical therapy 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 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 da
15. 4 Diagram 3 GYNECARE THERMACHOICE Single Use Balloon Catheter Version 1 2 and Umbilical Cable Depth sound measurement cm Fluid fill valve Fluid fill port for syringe Trumpet valve x Soft luer 3 AQ Heater Connection plugs Umbilical cable Pa S Pressure Front Panel of Controller Catheter heater temperature display C P play eo Hazard light Intra balloon Start button pressure display mmHg Message display THERMA CHOICE Y x X j J GYNECARE PRESSURE mmHg TEMPERATURE C C TIME minss00 Do oe MM CIRCULATION PRESSURELNE UMBILICAL CABLE Total time display Power minutes seconds switch Stop button Connection port for reusable 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 Do not remove the plug The circulation port is not used for this version of the catheter Rear Panel of Controller c B sut CAUTION Cln O TERGAN Connection port for AC power cord GYNECARE THERMACHOICE UBT System Operating Manual Page 5 CONTRAINDICATIONS The device is contraindicated for use in A patient who is pregnant or who wants to become
16. ATHETER Once catheter is connected PRIME CATHETER the Message Display will read The pressure line MUST be connected to the controller BEFORE the balloon catheter is filled with fluid or the device will not function properly Page 18 2 0 2 1 2 2 2 3 2 4 2 5 2 6 3 0 3 1 3 2 3 3 3 4 3 5 CATHETER PRIMING FILL the 30 ml syringe with approximately 5 10 ml consistency w 2 4 of sterile injectable 5 dextrose in water DsW Use only sterile injectable 5 dextrose in water DsW Use of other fluids may compromise system CONNECT the syringe to the port in the proximal end of the balloon catheter Do not overtighten syringe when connecting Point balloon catheter tip downward Press trumpet valve on top of balloon catheter handle and slowly fill with 5 10 ml of DsW Ensure that the pressure does not go above 200 mmHg indicated by the pressure display on the controller Press trumpet valve and evacuate fluid and air from balloon to a negative pressure of 150 to 200 mmHg indicated by pressure display on controller Note You may need to purge air from syringe several times to attain desired negative pressure You must release trumpet valve to maintain negative pressure Air should be completely evacuated to optimize the function of the device During priming when catheter pressure is PRIME CATHETER lt 150 mmHg the Message Display is 150 mmHg DO NOT EXCEED 200 mmHg negative
17. N AN AUTHORIZED GYNECARE SERVICE PERSON GYNECARE MAKES NO WARRANTY WHATSOEVER WITH REGARD TO Page 24 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 GYNECARE shall in no event be liable for any special indirect or consequential damages of any kind and however 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 SERVICING EQUIPMENT DISPOSAL 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 examinati
18. Operation Ambient temperature 10 40 C Relative humidity 20 to 85 non condensing Electromagnetic Compatibility ESD Direct amp Indirect Conforms to IEC 601 1 2 EMI Conforms to IEC 601 1 2 Leakage Currents Patient Leakage Current Conforms to IEC 601 1 Earth Leakage Current Conforms to IEC 601 1 ELECTROMAGNETIC INTERFERENCE In general sensitive electronic equipment should always be positioned as far away as possible from sources of high frequency voltages and currents such as electrosurgical 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 MAINTENANCE 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 possib
19. RB 40 9 years race body mass index mean baseline diary score IC 552 5 RB 570 and other parameters Page 10 Subject Withdrawals Table Ia Subjects GYNECARE THERMACHOICE ROLLERBALL Entered into study Intent to Treat Population 134 126 Procedure aborted 3 2 Receiving complete treatment 131 124 For whom 12 month data not available 10 Hysterectomy 2 3 Withdrew 1 4 1 daughter s death 1 menorrhagia 1 depression 1 amenorrhea 3 mo Lost to follow up 3 3 1 diary score 14 1 amenorrhea 3 mo 1 amenorrhea 3 mo 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 3 9 Hysterectomy 2 6 Lost to follow up 1 3 1 yr hypomenorrhea For whom 24 month data available 122 105 For whom 36 month data not available 8 Repeat Ablation 1 Hysterectomy 4 5 Lost to follow up 2 both hypomenorrhea 2 yr Withdrew 1 For whom 36 month data available 114 100 GYNECARE THERMACHOICE UBT System Operating Manual Page 11 RESULTS EFFECTIVENESS Table Ib 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 where
20. System GYNECARE THERMACHOICE UBT System 1 sterile disposable balloon catheter see catheter version matrix below and syringe 30 ml e 1 umbilical cable 1 controller power cord Catheter Version 3 0 Circulation catheter Silicone balloon Has fluid circulation mechanism inside the balloon Catheter Version 2 0 Circulation catheter Silicone balloon Has fluid circulation mechanism inside the balloon Catheter Version 1 2 Non circulation Latex balloon Does not have fluid catheter circulation mechanism GYNECARE THERMACHOICE UBT System Operating Manual Page 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 1 3 Make sure that the controller power is off before making the connection Steps 14 1 6 14 Plug the power cord into the back of the controller and into the wall outlet 15 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 nec
21. U S A Distribution Manufactured for Authorized European Representative GYNECARE ETHICON GmbH a Division of ETHICON INC Robert Koch Strasse 1 a Johnson amp Johnson company D 22851 Norderstedt Somerville N J 08876 0151 USA Germany Tel 1 877 ETHICON Tel 040 5297 01 EC Legal Manufacturer Gynecare a division of ETHICON INC a Johnson amp Johnson compan Somerville New Jersey 08876 0151 SYMBOLS USED ON LABELING AN See instructions for Use CE Mark and identification number C 0123 of Notified Body Product conforms to the essential requirements of the Medical Devices Directive 93 42 EEC GYNECAREY WORLDWIDE A division of E T H I C O NL sc a sfohwon company Somerville New Jersey 08876 0151 1994 1995 1996 GYNECARE Trademark VHERMACHOICE Uterine Balloon Therapy GYNECARE THERMACHOICE UBT System Operating Manual CE0123 GYNECAREY WORLDWIDE Adivision of E T H I C O Nywe a company Somerville New Jersey 08876 0151 us GB 389614 Table of Contents Page Device Descrip UOTL icu tec tere REPE NEU TA EXE EY A eeu ree amato EEE 1 Jiao itera tatea Lm 1 Contraindications neta etin E deret eee i tbv ee anter ie taped 6 WANNE S E 6 PHECAUTONS iSs 7 Adverse Events utendo tete ao di eibi oe e EO Hr eres 8 Other Adverse Bffects nemi enirn aon rend 8 Cmical Erial siccitate rtr deser eie rte eta debe ferae itd 9 Patient Population eim iet eiie
22. able ERROR DISPLAYED CODE 01 Page 30 TEXT SYSTEM ERRO1XX TURN POWER OFF SYSTEM ERRO2XX TURN POWER OFF SYSTEM ERRO3XX TURN POWER OFF CATHETER ERR50XX REPLACE CATHETER CATHETER ERR51XX REPLACE CATHETER CATHETER ERR52XX REPLACE CATHETER REMOVE FLUID REMOVE CATHETER OVERHEAT ERR53XX END PROCEDURE CATHETER ERR54XX END PROCEDURE REMOVE FLUID REMOVE CATHETER CATHETER ERR55XX END PROCEDURE REMOVE FLUID REMOVE CATHETER REASON Controller malfunction Controller malfunction Controller malfunction Catheter malfunction Catheter malfunction Catheter malfunction Fluid temperature between 90 C 95 C for 15 seconds Fluid temperature gt 95 C for 2 seconds Catheter malfunction ACTION Turn power switch off and REMOVE CATHETER then on again If error message persists return to GYNECARE for service 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 replace catheter Possible catheter failure Turn power off to clear error message and replace catheter Possible catheter failure Turn power off to clear error message and replace catheter Return controller to GYNECARE and for ser
23. by 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 lt 0 05 Table Ib Effectiveness Bleeding Rates Intention to Treat Groupt GYNECARE THERMACHOICE UBT ROLLERBALL n 134 n 126 Months Post Treatment 12 24 36 12 24 36 Number of Successful Patients 101 109 106 97 95 94 Study Success Rate 75 4 81 3 79 1 77 0 75 4760 74 6 of Patients with Amenorrhea Patients with diary scores 0 19 16 17 31 23 27 Amenorrhea Rate Patients with diary scores 0 14 2 11 9 12 7 24 6 18 2 21 4 a based on diary scores b based on telephone questionnaires Not Statistically Significant P gt 0 05 Statistically Significant P lt 0 05 tSee Table 1a for Subject Withdrawals Page 12 Table Ic 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 1a were not included in the calculations There were no statistically significant differences between groups Table Ic Effectiveness Quality of Lifet GYNECARE THERMACHOICE UBT ROLLERBALL Months Post Ablation 12 24 36 12 24 36 of Patients Who Responded to Quality
24. e f a perforation is suspected THE PROCEDURE SHOULD BE TERMINATED 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 THERMACHOICE 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 THERMACHOICE III UBT catheter controller and umbilical cable are designed as a system To ensure proper function never use other components with the GYNECARE THERMACHOICE UBT System A starting pressure of 160 180 mmHg is recommended and typically requires 6 15 ml of fluid and may require as much as 30 ml 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
25. essary 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 Page 16 Diagram 4 GYNECARE THERMACHOICE IIIC Silicone Balloon Catheter with Fluid Circulation Version 3 0 Catheter umbilical cable connection BS Match arrows together Remove the plug before connecting the circulation catheter Align red dots from umbilical cable to controller Umbilical cable Circulation catheter connection Pressure line filter Ensure a snug connection GYNECARE THERMACHOICE IIC Silicone Balloon Catheter with Fluid Circulation Version 2 0 Catheter umbilical cable connection BELLO Match arrows together Detail A 7 A Remove the plug before connecting the circulation catheter Align red dots from umbilical cable to controller Umbilical cable Circulation catheter connection Pressure line filter Ensure a snug connection GYNECARE THERMACHOICE UBT System Operating Manual Page 17 1 6 1 7 1 8
26. g 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 GYNECARE THERMACHOICE UBT System Operating Manual Page 21 4 4 4 5 5 0 5 1 5 2 5 3 5 4 5 5 5 6 5 7 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 When the treatment cycle is completed the Message Display will alternate between the following messages THERAPY d COOLING DOWN COMPLETED an PLEASE WAIT The controller automatically terminates the heater at the end of the treatment cycle and an audible alarm will sound POST TREATMENT The cool down cycle takes 30 seconds When the cycle is completed the Message Display will read the following THERAPY amp COOL REMOVE FLUID DOWN COMPLETED then 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 Disconnect the
27. he wall outlet before cleaning 2 Usea cloth dampened with 50 water and 50 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 luer lock using a cotton swab with 50 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 Page 28 4 0 5 0 DISINFECTION 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 of 50 water and 50 isopropyl alcohol Use only 50 water and 50 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 POWER CORD 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 my GYNECARE THERMACHOICE UBT System Operating Manual Page 29 Error Code T
28. heter END PROCEDURE Return controller for repair PREHEAT ERROR or Treatment temperature and or Remove fluid OVERHEAT ERROR or pressure is outside standard Remove balloon catheter UNDERHEAT ERROR or operating parameters PRESSURE ERROR and END PROCEDURE WARRANTY GYNECARE a Division of ETHICON 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 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 THA
29. ie ierit ri ete e e tinea 10 Patient S lection renean n ruri pa eur e Hk erra reb oen agus 14 Patient Counseling nonien feet rore e eee ber reete ie 14 Pretreatment Preparation of Patient issii ssri ea 15 Directions fot Use eterne nip inrer rerba ne uno 15 SEAE M 15 Catheter Priming aaepe nre neni eerte rete da 19 Pressure THraAtIO ictor etr rper rd Uer tege EEES ri ero 19 gcc 21 Post Ireatment iuditio riim entities ite ec n n 22 Operating Parameters Alarm and Display Messages 22 Error MeSSag bess acess 23 More 24 Servicing Equipment Disposal sss 25 Ordering Information irent reiten rtr er ber ERROR Ee rsa 25 Specifications Controller amp Umbilical Cable sss 25 Environmental Conditions rrr nri rr rnit rnit 26 Electromagnetic Interference eese rene ntr netter terrea 26 Maintenarice n ocn diede e nere ien imn bn eh Fia re ia 26 Cali Drationy X 26 Fuse Replacement istis n ripetere tor DR SOR A RS IHRE HS eee RE 28 Cleaning Controller System sisisi siinseist 28 Disinfection Umbilical Cable sss 29 Power Cord M ae aeia iaa aa ee a 29 GYNECARE THERMACHOICE UBT System Operating Manual GYNECAREY WORLDWIDE A division of E T H I Co Nine a afohmon company Somerville New Jersey 08876 0151 THERMACHOICE Uterine Ball
30. isplay a message indicating the cause The following chart explains operating parameters for temperature time and pressure Standard Range Alarm Heater Shut off Limits Temperature 87 C 75 90 C Over gt 95 C for 2 seconds or between 90 94 C for 15 seconds Under lt 75 C for 15 seconds Pressure 70 210 mmHg Over gt 210 mmHg for 2 seconds Titrate to 160 180 mmHg before starting procedure Under lt 70 mmHg for activation pressure 2 seconds minimum starting pressure gt 150 mmHg Time Over gt 4 minute pre heat 8 minute therapy cycle after reaching 87 C preheat phase or failure to achieve temperature of 87 C within 4 minute preheat phase 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 Alert Warning Temperature Over gt 90 C amp lt 95 C for 2 seconds Under lt 83 C for 2 seconds Pressure Over gt 200 mmHg amp lt 210 mmHg for 2 seconds Under gt 70 mmHg amp lt 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 terminate the procedure with an error code In this case turn off the power to the
31. le 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 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 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 Page 26 1 2 Trumpet valve PN 55402601 Braun Medical Inc 824 Twelfth Ave PO Box 027 Bethlehem PA 18018 0027 Telephone 800 227 2862 T connector PN T20 1 Value Plastics Inc 3350 Eastbrook Dr Fort Collins CO 80525 Telephone 970 223 8306 Tubing 0 093 ID 0 156 OD Norton Performance Plastics Corp PO Box 660 Akron OH 44309 3660 Telephone 800 798 1539 Male luer lock adapter PN B0850402 Braun Medical Inc 824 Twelfth Ave PO Box 4027 Bethlehem PA 18018 0027 Telephone 800 227 2862
32. n 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 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 e 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 e 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 e Endometritis was reported in 2 1 of patients All patients responded to a course of oral antibiotics e Post procedure symptoms such as pain fever nausea
33. n to tear or the catheter to perforate the uterine wall If a perforation is suspected at this point perform appropriate diagnostic measures to evaluate for perforation before proceeding If perforation can not be ruled out abandon the procedure 3 7 Press trumpet valve on top of balloon catheter and fill balloon slowly to pressure of 160 180 mmHg using 2 30 ml of DsW Release the trumpet valve to allow the pressure to stabilize Do not allow the pressure to exceed 200 mmHg during titration Incrementally add small volumes to achieve a stable pressure no fluctuations greater than 10 mmHg of 160 180 mmHg for a minimum of 30 seconds The pressure of the balloon against the uterine wall often precipitates uterine contraction thereby temporarily increasing the pressure reading If pressure cannot be stabilized at 160 180 mmHg for 30 45 seconds with 30 ml of fluid this may indicate uterine perforation Remove the balloon catheter If a balloon leak is present replace the catheter and continue with the procedure If no balloon leak is found perform appropriate diagnostic measure to evaluate for perforation before proceeding If perforation cannot be ruled out abandon the procedure Note Once the heater is activated the pressure may initially rise 10 20 mmHg the pressure may then drop slowly for the remainder of the procedure The ending balloon pressure may be as low as approximately 100 mmHg and is typically between 120 150 mmHg Note I
34. ngerous 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 PRETREATMENT PREPARATION OF PATIENT 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 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 DIRECTIONS FOR USE Please read all directions precautions and warnings prior to use 10 SET UP 11 The following items are required for use of the GYNECARE THERMACHOICE UBT
35. of Life Questionnaire 125 122 114 114 105 100 Patients with anemia pre treatment HCT 29 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 Patients reporting severe impact on life pre treatment 70 3 70 3 70 3 78 6 78 6 78 6 Patients reporting severe impact on life post treatment 3 2 4 9 1 8 1 8 1 0 2 0 tSee Table 1a for Subject Withdrawals SAFETY Table II 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 Table II Safety Post operative adverse events 1 post coital bleeding 3 endometritis 1 PATSS post ablation tubal sterilization syndrome Not Statistically Significant P gt 0 05 Statistically Significant P lt 0 05 GYNECARE
36. on 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 amp 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 sient riter eret 250 VAC 5 x 20 mm 1 6 A standard MECHANICAL CHARACTERISTICS DIMENSIONS sssi saestoe Height 10 2 cm 4 in width 41 2 cm 16 25 in depth 37 0 cm 14 56 in Weight ossessi 6 9 kg 15 3 lbs controller only Case Aluminum and impact resistant plastic Umbilical Cable ee Length 152 cm 60 in GYNECARE THERMACHOICE UBT System Operating Manual Page 25 ENVIRONMENTAL CONDITIONS Transport and Storage Ambient temperature ss 20 to 50 C Relative humidity szin 20 to 85 non condensing
37. oon Therapy Thermal Balloon Ablation System Read all directions precautions and warnings prior to use This manual provides directions for using the GYNECARE THERMACHOICE Uterine Balloon Therapy UBT System Caution Federal law USA restricts this device to sale by or on the order of a physician with appropriate training 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 6 dextrose in water DsW 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 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 fl
38. patients were gt 30 years old premenopausal and had completed childbearing All had an anatomically normal uterine cavity gt 4 cm and 10 cm GYNECARE THERMACHOICE UBT System Operating Manual Page 9 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 e 260 patients in Safety Evaluation Group 134 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 e 255 patients treated with test or control device 131 TC 124 RB Baseline demographic physical exam and gynecological variables were statistically equivalent between the test and control groups with regard to age TC 40 2 years
39. pleted 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 1 none 10 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 diary scoring system adapted from Higham JM O Brien PMS Shaw RW Assessment of menstrual blood loss using a pictorial chart Br J Obstet Gynaecol 1990 97 734 9 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 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
40. 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 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 tubal ligation are at increased risk of developing post ablation tubal sterilization syndrome which can require hysterec
41. pressure during evacuation The negative pressure creates a low profile balloon insertion balloon is drawn tight against catheter tip Do not go beyond 200 mmHg Check that negative pressure is maintained for at least 10 seconds before proceeding Once catheter pressure is gt 150 mmHg INSERT CATHETER amp the Message Display is FILL WITH DjW If negative pressure cannot be maintained for 10 seconds remove the balloon catheter and replace PRESSURE TITRATION Fill syringe to 30 ml with DsW purge air and connect to balloon catheter do not overtighten Do not use more than 30 ml of DsW Measure depth of uterus Using appropriate sterile technique and cervical vaginal preparation dilate cervix to 5 mm if necessary If a perforation is suspected at this point perform appropriate diagnostic measures to evaluate for perforation before proceeding If perforation can not be ruled out abandon the procedure Wet the outside of balloon with DsW After sounding the uterus and wetting the balloon SLOWLY INSERT THE BALLOON CATHETER into the uterus until the tip is touching the fundus Ensure that the depth indicated by markings on catheter is consistent with GYNECARE THERMACHOICE UBT System Operating Manual Page 19 previous sound measurement Use a tenaculum to hold the cervix if necessary 3 6 Ensure that the cervix is dilated to 5mm and do not use excessive force during insertion as such force can cause the balloo
42. t is recommended that for very small uteri pressure titration should occur towards the lower end of the range i e Use a minimum amount of fluid to reach 160 mmHg This will reduce the potential for increase of pressure during the thermal treatment that might result in overpressure and system shutdown Note Positioning the device in a false passage may allow the balloon to reach operating pressure with a small amount of fluid This may be misinterpreted as being a small uterine cavity Care should be taken to insure the device is properly positioned in the uterine cavity Do not over pressurize balloon during titration Optimal balloon volume depends on the potential volume of the uterine cavity and is typically 6 15 ml at 2160 mmHg at start and may be as great as 30 ml If pressure level cannot be reached with 30 ml of fluid remove balloon catheter and check for uterine perforation and or balloon catheter leak Replace balloon catheter if necessary Page 20 4 0 4 1 4 2 4 3 TREATMENT RUNDE Message Display alternating 5 play 8 PRESS START and STABILIZE START PRESSURE gt 150 When a steady pressure of 160 180 mmHg is maintained press START lt gt 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
43. tomy 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 amp 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 GYNECARE 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 Page 6 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 a maximum of 30ml of fluid 3 If the pressure drops quickly at any point during the procedure
44. uid circulation mechanism inside the balloon See Diagram 2 c 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 GYNECARE THERMACHOICE UBT System Operating Manual Page 1 Diagram 1 GYNECARE THERMACHOICE IIIC Single Use Silicone Balloon Catheter with Fluid Circulation Version 3 0 and Umbilical Cable Depth sound measurement cm Silicone Fluid fill valve Fluid fill port for syringe Trumpet valve N EI Catheter umbilical Heater cable connection Circulating element Connection Front Panel of Controller Catheter heater Umbilical cable temperature display C Hazard light Intra balloon Start button Start pressure display button mmHg Message display light C THERMA CHOICE Uterine Balloon Theraj Py Xd J l EQ PRESSURE meo D rewrenarune co OTME GYNECARET GIRCULATION PRESSURE LINE Total time display minutes seconds Stop button Connection port for
45. vice Return controller to GYNECARE for service Possible catheter failure Turn power off to clear error message and replace catheter Error Code Table 56 57 58 59 60 61 62 63 64 65 CATHETER ERR56XX END PROCEDURE REMOVE FLUID REMOVE CATHETER CATHETER ERR57XX END PROCEDURE REMOVE FLUID REMOVE CATHETER CATHETER ERR58XX END PROCEDURE REMOVE FLUID REMOVE CATHETER OVERHEAT ERR59XX END PROCEDURE REMOVE FLUID REMOVE CATHETER OVERHEAT ERR60XX END PROCEDURE REMOVE FLUID REMOVE CATHETER OVERHEAT ERR61XX END PROCEDURE REMOVE FLUID REMOVE CATHETER PRESSURE ERR62XX END PROCEDURE REMOVE FLUID REMOVE CATHETER PRESSURE ERR63XX END PROCEDURE REMOVE FLUID REMOVE CATHETER HEATER ERR64XX END PROCEDURE REMOVE FLUID REMOVE CATHETER HEATER ERR65XX END PROCEDURE REMOVE FLUID REMOVE CATHETER Catheter malfunction Catheter malfunction Catheter malfunction Fluid temperature between 90 C and 95 C for 15 seconds Fluid temperature gt 95 C for 2 seconds Fluid temperature 2105 C for 2 seconds Under pressure Pressure 70 mmHg for 2 seconds Over pressure Pressure 2210 mmHg for 2 seconds Fluid temperature 87 C during entire 4 minute preheat cycle Catheter malfunction Possible catheter failure Turn power off to clear error message and replace catheter Possible catheter
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