GYNECARE THERMACHOICE® III Uterine Balloon
Contents
1.2. is a normal reaction as uterus contracts then relaxes ETHICON doo doa PART OF THE Yemen er hon FAMILY OF COMPANIES 23 Treatment 15 Controller automatically terminates heating at end of therapy cycle Total treatment time will be displayed on controller preheat time therapy time Shapi ETHICON poy PART OF THE fohmonafohmen FAMILY OF COMPANIES of surgery 24 Post Treatment 16 Wait 30 seconds for fluid to cool Message displays when cool down is completed 17 Remove all fluid from balloon Remove and discard catheter Retain umbilical cable and disinfect for next case Following 20 uses discard umbilical cable and replace Shapi ETHICON 20 PART OF THE fohmonafohmen FAMILY OF companies Of surgery 25 For detailed instructional steps on the use of the GYNECARE THERMACHOICE III Uterine Balloon Therapy System please refer to the Instructions for Use or System Operating Manual For all product details including a complete list of warnings precautions adverse events indications and contraindications please reference the Instructions for Use and System Operating Manual Customer Support For product use assistance clinical guidelines service and repair emergency assistance or complaints please contact our Customer Support Center at customersupport eesus jnj com or by calling 1 877 ETHICON 384 4266 Our Support Center is staffed 24 hours a day 7 days a week by qualified nurse
3. GYNECARE THERMACHOICE III Uterine Balloon Therapy System In service Cynthia Pypcznski Paulette Gengenbacher September 2nd 2015 pp ETH ICON le THE fohmonafohmen ram OMP de Lo Agenda e Overview e Steps for Use e Product Demonstration Video e Troubleshooting e Q amp A e Enhanced Support Options gt e Wrap up Overview GYNECARE THERMACHOICE II Uterine Balloon Therapy System A thermal balloon ablation device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia excessive uterine bleeding due to benign causes for whom childbearing is complete Shapi ETHICON ir PART OF THE fohmonafohmen ty oF companies Of surgery 1 GYNECARE THERMACHOICE Ill Instructions for Use 2010 Ethicon Inc 4 Device Operation and Coverage e 160 180 mmHg and 87 C 188 F applied to endometrial lining e Maintained temperature results in thermal ablation of endometrial tissue e Can conform to various shaped uteri ETHICON fe PART OF THE fohmonafohmen FAMILY OF companies Of surgery GYNECARE THERMACHOICE III Uterine Balloon Therapy System e 1 sterile disposable balloon catheter and 30 cc syringe e 1 umbilical cable e 1 controller with circulation port e 1 power cord Medical Supplies e 50 cc sterile injectable plain 5 dextrose in water D W e Sterile drape for umbilical cable optional e Uterine sound cervical dilator s e Tenaculum weight
4. ed speculum Note Use only plain D W to inflate balloon catheter never use any other fluid ETHICON ie PART OF THE folumonafohmeon FAMILY OF COMPANIES Of surgery GYNECARE THERMACHOICE III Uterine Balloon Therapy System 1 Power Cord 4 Pressure Line 6 Trumpet Valve 2 Controller 5 Circulation 7 Silicone Balloon 3 Umbilical Cable Connection 8 Circulating Element ETHICON ie FAMILY OF COMPA PART OF THE fohmonafohmen mes Of surgery GYNECARE THERMACHOICE III Uterine Balloon Therapy System Depth Sound Measurement cm Silicone EN Balloon Fluid Fill Valve Trumpet valve Fluid Fill Port for Syringe m m CT 3 Catheter Umbilical u 3 Heater Cable Connection twr n Pressure Line gt N Circulation Pressure Line N Catheter Filter N B N A Connection G LZ A li Circulating Element Connection Plugs Umbilical Cable EII O IN ire PART OF THE Johmonlohmen FAMILY OF COMPANIES Of surgery 8 Make all connections before turning controller power on or adding fluid Disinfect umbilical cable per Operating Manual Drape umbilical cable with sterile drape if necessary PART OF THE Gohwwonallohwwon Family or companies OT SUrgery 10 Steps for Use Make all connections before turning controller power on or adding fluid 2 Connect catheter pressure line to controller Luer lock Do not over tighten but ensure it is fully connected Handle balloo
5. function properly pm 2 0 L q m y pp A TE LL st 7 Prime catheter by pointing tip down pressing trumpet valve and filling SLOWLY with up to 20 cc D W NE Ensure balloon is fully deployed When adding fluid during priming ensure balloon fully opens so that no sides are touching Then press valve to SLOWLY evacuate fluid and air from balloon to 150 to 200 mmHg as indicated by pressure display on controller DO NOT EXCEED 200 mmHg negative pressure during evacuation Excessive negative pressure can lead to greater pressure fluctuation during treatment ETHICON ie PART OF THE fohmonafohmen FAMILY OF COMPANIES Of SUrgery 16 Fill syringe to 30 cc with D W purge air and connect to catheter do not over tighten but ensure snug connection Up to 5 cc additional fluid may be used if needed for a total of 35 cc ETH ICON nm A E a En the fu ture PART OF THE folmonsfohmen FAMILY OF COMPANIES Of surgery 17 PART OF THE ofen d lohen FAMILY OF COMPANIES Wet outside of balloon with DoW PART OF THE ofmronallofhmon FAMILY OF COMPANIES After sounding uterine depth and wetting balloon SLOWLY INSERT BALLOON CATHETER into uterus until tip Is touching fundus Ensure that depth indicated by markings on catheter is consistent with previous sound measurement Use tenaculum to hold the cervix if necessary Ensure that the cervix IS dilated to 5mm and do not use exce
6. ith 35 cc of fluid remove balloon catheter and check for uterine perforation and or balloon catheter leak Replace balloon catheter if necessary T Shaping F H I C O N the future Safety and effectiveness have not been established in patients with DF THE i FAMILY OF COM ais sant ane mass OF SUrgery small uterine cavities lt 2 cc in volume or uterine sound lt 6 cm Pressure Mitigation During Treatment e 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 e 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 of at least 30 seconds remove the fluid and then remove the balloon catheter and abort the procedure A work up for perforation should be considered prior to discharge ETHICON fen PART OF THE folumonafohmeon FAMILY OF COMPANIES Of surgery Enhanced Support Options Support Services e Live Customer Support e Training and Educational Resources e Product Information ETHICON fen PART OF THE fofumenafolmon FAMILY OF COMPANIES of surgery Live Customer Support Contact Ethicon for Live Procedural Suppo
7. n portion of catheter carefully to prevent damage Shapi ETHICON 1 PART OF THE fohmonafohmen FAMILY OF COMPANIES of surgery 11 Steps for Use Make all connections before turning controller power on or adding fluid 3 Plug circulation catheter plug into controller circulation port Avoid loops kinks or bends to reduce the potential of motor fault issues Shapi ETHICON ie PART OF THE fohmonafohmen FAMILY OF COMPANIES Of surgery 12 4 Connect umbilical cable to catheter line up arrows on umbilical cable to notch arrow on catheter s cable receptacle Shapi ETHICON ie PART OF THE fohmonafohmen FAMILY OF COMPANIES Of surgery Setup ETHICON PART OF THE folumonafjolumen Famy or COMPANIES Shaping the future of surgery 5 Turn on controller power Catheter Priming and Pressure Titration Note Pressure line MUST be connected to controller BEFORE balloon catheter is filled with fluid or device will not function properly lz 6 Fill syringe with up to 20 cc sterile D W Connect syringe to catheter Do not over tighten but ensure snug connection il Vila Note Use only plain D W to inflate balloon catheter never use any other fluid Shapi ETHICON ie PART OF THE fohmonafohmen FAMILY OF COMPANIES Of surgery 15 Catheter Priming and Pressure Titration Note Pressure line MUST be connected to controller BEFORE balloon catheter is filled with fluid or device will not
8. on Confirm uterus is no larger than 10 cm Ensure trumpet valve is released during titration ETHICON ve PART OF THE folumonafohmeon FAMILY OF COMPANIES Of surgery Pressure Mitigation During Catheter Priming e 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 e During priming when catheter pressure is lt 150 mmHg the Message Display is Prime Catheter lt 150mmHg e DO NOT EXCEED 200 mmHg negative pressure during evacuation ETHICON ve PART OF THE folumonafohmeon FAMILY OF COMPANIES Of surgery Pressure Mitigation During Pressure Titration e When pressing trumpet valve on top of balloon catheter and filling balloon slowly to pressure of 160 180 mmHg using 2 35 cc of D W 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 e If pressure cannot be stabilized at 160 180 mmHg for 30 45 seconds with 35 cc of fluid this may indicate uterine perforation Remove the fluid and then remove
9. rt Equipment Troubleshooting or Repair Emergency Assistance or Product Ordering Live Virtual Case Coverage e Schedule a representative to be available by phone for your procedure call 877 ETHICON 384 4266 Option 3 or schedule by e mail at techsupport1 its jnj com Equipment Troubleshooting and Repair e Calibration repair and loaners call 877 ETHICON 384 4266 Option 3 Emergency Procedure Support and Troubleshooting e Available 24 7 877 ETHICON 384 4266 Option 4 Chat Live e Available 7 30AM 6 30PM EST Monday Friday Product Ordering To order GYNECARE THERMACHOICE Uterine Balloon Therapy System or supplies call 800 255 2500 or www jnjgateway com ETHICON ve PART OF THE folumonafohmeon FAMILY OF COMPANIES Of surgery Training and Educational Resources Videos and educational brochures are available on ethicon com including e In service video e Procedure video e Patient brochures Available for office use from 877 ETHICON 384 4266 ETHICON PART OF THE fohmonsfokmeon FAMILT OF COMPAHIES Shaping the future of surgery Product Information Center Additional resources available on ethicon com Product overview Description amp specifications Sales aid Brochures Science technology Reimbursement guide FU Latex information User service manual ETHICON fri me fohmona ohmsen ram ames Of surgery Thank You O 2015 Ethicon US LLC All rights reserved 039593 150901
10. s and biomedical technicians to answer your product related questions For any product issues please file a complaint and return the disposable product without any additional field testing or tampering of product Shaping the future pan es Of surgery 26 ETHICON PART OF THE Gofmonalofmon FAMILY OF COMPA Product Demonstration Video This demonstration is meant to complement the official Instructions for Use and Operating Manual not to replace them Before proceeding with the GYNECARE THERMACHOICE III Uterine Balloon Therapy System procedure please consult the GYNECARE THERMACHOICE III Uterine Balloon Therapy System Operating Manual ETHICON ie PART OF THE folmonafjolmon Famy or COMPANIES of surgery 29 Troubleshooting Optimal Device Performance e Unable to maintain negative pressure during catheter priming Trumpet valve must be released to maintain negative pressure Make certain to fill catheter with balloon tip in down position Negative pressure only needs to be maintained for a minimum of 10 seconds e Unable to achieve temperature Typically occurs when gt 35 cc D W used e Once cycle begins pressure will vary e Unable to maintain pressure during catheter priming balloon leaks Check Luer lock and make sure pressure line is properly connected Make sure to wet balloon with D W solution prior to inserting in uterus e Unable to sustain positive pressure during titrati
11. ssive force during insertion as Such force can cause the balloon to tear or the catheter to perforate the uterine wall Catheter Priming and Pressure Titration 11 Fill balloon slowly to 160 180 mmHg pressure using 2 35 cc D W Add fluid as necessary to titrate pressure Do not use gt 35 cc VERY IMPORTANT Allow pressure to stabilize to 160 180 mmHg for a minimum of 30 seconds before pressing START button Note Activation pressure minimum starting pressure is 2150 mmHg Shapi ETHICON ie PART OF THE folmonafjolmen FAMILY OF COMPANIES Of surgery 20 lol KON sjohnsen FAMILY OF COMPANIES Shaping the future of surgery After pressure has been stable above 150 mmHg for at least 10 seconds green START button will flash indicating procedure cycle can begin Push START button on controller Hold catheter immobile and centered during procedure Note Ensure balloon catheter is centered in uterus to minimize potential overheat error codes and catheter failure 21 Treatment 13 Controller activates preheat cycle to heat fluid to 87 C Preheating may take up to 4 minutes Once 87 C is reached an audible tone will indicate automatic activation of the 8 minute cycle Shapi ETHICON igen PART OF THE fohmonafohmen FAMILY OF COMPANIES Of surgery 22 Controller automatically activates 8 minute therapy cycle Note Pressure may rise initially and then fall gradually during procedure This
12. 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 e 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 ETHICON ie PART OF THE folumonafohmeon FAMILY OF COMPANIES Of surgery Pressure Mitigation e It 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 e 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 e Do not allow pressure to exceed 200 mmHg during titration e Optimal balloon volume depends on the potential volume of the uterine cavity and is typically 6 20 cc at gt 160 mmHg at start and may be as great as 35 cc If pressure level cannot be reached w
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