1. Nurse Educational Program on Genesys HTA™ System

2. Agenda Global Endometrial Ablation (GEA) Overview
Benefits of Genesys HTA™ System
Genesys HTA System Procedure Overview
Set Up
Procedure
Break Down
Learn Troubleshooting Techniques
Read slides. Remember, this content was created by nurses for nurses

3. Objective
To learn efficient and effective set up and operation of the Genesys HTA™ System
Read slide.

4. Global Endometrial Ablation Devices – FDA Approval Dates
1997
2001
2003
2007
1994
2010
Rollerball
HTA® System & Novasure® System
Thermachoice® III Device
Thermachoice® I Device
Thermachoice® II Device
Genesys HTA™ System
The goal for this slide is to communicate the advances of GEA technology and how advanced the Genesys HTA™ System and meets unmet needs
Rollerball  - +direct visualization, good results / -hard to operate, complications
Thermachoice® I Device - +easy to operate, safe / -poor results, no visualization, hard to treat irregular cavities
Novasure® System - +easy to operate, safe, good results / -no visualization, hard to treat irregular cavities
HTA® System - +good results, can treat irregular cavities, direct visualization / -complicated to set up, vaginal burns
Genesys HTA™ System - +good results, can treat irregular cavities, direct visualization, easy to set up, fixed vaginal burn issue
There have been issues with all devices           -  Genesys has newest advancement           - Meets the unmet needs of the original HTA
Global Endometrial ablation devices are continually evolving to meet physician and patient needs

5. Genesys HTA™ System – Evolution
2001
2005
2006
2009
2010
HTA® System Time Line
Launch of
HTA System
Launch of
Tenaculum
Stabilizer
Disposable
Heater Canister
HTA ProCerva® Sheath
Genesys HTA
System
Flow Rates* -
HTA System cc/min (Mean)
Genesys HTA System – 332 cc/min (Mean)
Number of Sensors to detect a Fluid Loss* -
HTA System – 3
Genesys HTA System – 24
Time Savings* –
Genesys HTA System vs. HTA System
- Total time savings- 4:44 minutes
Improvements have made Genesys HTA safer & more efficient
*Data on File- Boston Scientific.
Based on 9 Users . Results may vary.

6. Genesys HTA™ System Benefits

7. The Genesys HTA™ System Benefits
The Genesys HTA System is designed for easy set up and intuitive operation to deliver a safe, effective and versatile treatment for menorrhagia.
Read slide

8. Easy Set Up Compact cassette with drop in loading One step fill stage
Easy shut down and restart for quick case turn around
One set up for ablation and concomitant hysteroscopy
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9. Intuitive Operation Dynamic LCD screen Step by step instructions
On screen display of alerts and alarms
Audio cues
Including Seal Integrity check
Read slide

10. Designed for Safe Use HTA ProCerva® Fins New Sieve Tip
Seal Integrity Check
Designed to help verify cervical seal before heat up
Fluid monitored during entire procedure
Genesys HTA ProCerva® Sheath
Redesigned to gain and maintain a seal at the cervix with 16 redundant soft silicone fins
Incidence of burns since Genesys HTA ProCerva Sheath Introduction % (As of February 29, 2012)
Tapered sieve tip
Return surface area increased ~ 500%
Designed to help prevent clogs
Direct visualization throughout entire procedure (Before, during and after)
Low pressure (50-55mmHg)
Focus on BOLDED words. These are the key takeaways.
New Sieve Tip
Data on File- Boston Scientific

11. Effective
Patient Satisfaction
Amenorrhea
Eumenorrhea
The highest Phase III clinical amenorrhea rates at three years1
Read slide
36 Months2
When compared against Novasure® System, ThermaChoice® I Device and Her Option® System. Evaluated population on the HTA® System. Carter JF, Endometrial Ablation: More Choices, More Options The Female Patient ;30(12):35-40.
Evaluated Population, treated with HTA System (72/136). Goldrath MH, Evaluation of HydroThermAblator and Rollerball Endometrial Ablation for Menorrhagia 3 Years after Treatment. The Journal of the American Association of Gynecologic Laparoscopists. November 2003, Vol. 10, No. 4.

12. Versatile Potential to treat a wide variety of uterine cavities1
Intramural fibroids (≤4cm)
Designed to be compact & quiet – Can potentially be use in either in the Office or Operating Room2
Continuous hysteroscopic monitoring
Read slide. This show’s Genesys HTA System can treat various sizes and shapes of cavities and be used in OR or In-office.
1. Evaluated population on the HTA® System. Carter JF, Endometrial Ablation: More Choices, More Options The Female Patient ;30(12): Reilly GP, Can Endometrial Ablation Technique Effectiveness Be Properly compared without considering the uteruses treated?
2. Phillips R, Schultz M, Patient Pain Tolerance of In-Office HydroThermal Ablation AAGL Podium presentation.

13. Use with Essure® Device
The FDA has approved the use of the HTA® System after placement of Essure Mircroinserts1
Following 3 month HSG confirmation test1
Read Slide
1. Essure – ESS305 Instructions for Use- pg. 1

14. Genesys HTA™ System Procedure Overview

15. What is HydroTherm Ablation? An Overview
The HTA System is an endometrial ablation system that introduces free saline into the endometrial cavity under hysteroscopic guidance. After introduction the saline is heated to 90ºC and circulated for 10 minutes, thereby treating the endometrium by a thermal effect. The fluid is maintained at low pressure, designed to avoid egress through the fallopian tubes. The new HTA ProCerva™ Sheath is designed for assisting in gaining and maintaining a seal at the cervix.

16. Equipment Needed for Genesys HTA™ System*
Genesys HTA System (control unit)
Genesys HTA ProCerva® Procedure Set
3 Liter bag of saline
Scope adapter
3mm or smaller rigid hysteroscope
Read Slide – These are the key things needed for a procedure.
*Refer to Genesys HTA System User Manual for a complete list of equipment needed

17. Set Up, Procedure, Break Down
Read, discuss, decide
The key takeaway is that using Genesys HTA™ System is REALLY easy, just “Read, Discuss, Decide” – Read what is on the screen and follow the instructions. Stress importance of “Ease of Use”.

18. System Setup: Cassette; Drainage Bag
At this point, invite a member of the audience up and have them “Set up” and run through a mock procedure. You will narrate, to the audience, what is happening in each step of setup, procedure and break down.
Ensure to tell them to push the purple buttons, not the screen (Reaffirm on the upcoming screens as well). Press the “Engage Cassette” to continue.

19. System Set Up: Checking Cassette
Read title.

20. System Setup: Saline, Sheath, Adapter, Scope, Cap
Read title. This screen continues the setup. As you can see, it provides you all the information you need to correctly setup the system. (Walk the person upfront through the next setup steps)
Remind them that there are 2 purple buttons to push – this is not a “touch screen”.
Press the “Fill system” to continue

21. System Preparation: System Initializing & Filling
Read title. Let them know that the screen will tell you everything you need to know and what is happening.

22. System Preparation: Preparing for Diagnostic Hysteroscopy
Read title – Again, it let’s you know what the system is doing.

23. Procedure: Set System Height to Uterine Level
All procedure steps up to this point can be performed prior to patient entering in room
Remind the group to set up the system, to this point, before the patient and physician enter into the room (As this takes a few minutes to do). As we all know, once the patient and physician enter the room, it is “go time” and nobody wants to wait for it to be set up. This will eliminate some potential frustration.

24. Procedure: Remove Sheath Cap & Insert Procedure Sheath into Patient
Read title slide. Again, each screen tells you everything you need to know about how to operate the Genesys HTA™ System. Press “Initiate diagnostic hysteroscopy” to continue.

25. Procedure: Diagnostic Hysteroscopy
Read title slide. Now you are performing diagnostic hysteroscopy. Press “Continue to Ablation Preparation” to continue.

26. Procedure: Ablation Preparation
Read title. This let’s you know you are getting ready to being the “Heat up” phase. Press “Continue Preparation” to continue.

27. Procedure: Ablation Preparation – Seal Integrity Check
Read title slide. Press “Initiate Ablation” to continue.

28. Procedure: System Heating to Ablation Temperature
Saline will heat up to
80◦C, then 10 minute
ablation cycle will start
Read title & gray box to left of screen.

29. Procedure: Hit Pause?
If “pause” button is pressed, this is the screen that appears. This screen always is displayed to “Confirm Cancellation”, so no accidental shutdown occurs.

30. Procedure: Ablation Procedure
Saline will continue to heat up to 90◦C
Read title and gray box.

31. Procedure: Cooling and Flushing
Read title. After the 10 minute ablation cycle is complete, the system will automatically begin to go into the “Cooling and flushing” cycle.

32. Procedure: Patient Cooling Complete
Read title. At this point, the physician can elect for “Additional Diagnostic Hysteroscopy” or “Continue to System Shutdown”. The physician can release the tenaculum stabilizer as well.

33. Procedure: Procedure Complete
Read title. At this point, if “Continue to System Shutdown” is selected, then the physician can remove the sheath from patient. (Ensure the “Release of the Tenaculum Stabilizer”

34. Break Down: System Shutdown
Read title. Walk participant through how to take apart the system after the procedure.

35. Break Down: System Shutdown
Read title. Again, remind the audience that there are 2 purple buttons to push and that this system is not a “touch screen”. Finish breaking down the machine. Have participant return to seat.

36. Procedural Reminders Reminders*:
Continuously monitor the cervical seal
Avoid allowing the procedure sheath tubing to contact patient
Avoid moving or removing the procedure sheath until the post-treatment cooling cycle has been completed
Avoid over-dilatation
Maintain a stable sheath position throughout the procedure
Review these reminders with the audience (Each bullet point). Tell them it is important to know these and remind physicians if they see the physician doing something contrary to these suggestions.
* Refer to User’s Manual for all contraindications, warnings and cautions associated with using the Genesys HTA™ System
Image Source:  Master isolated images

37. Troubleshooting Alarms Read, discuss, decide
Refer to the User’s Manual for all troubleshooting information when using the Genesys HTA™ System
For alarms & troubleshooting, remind audience to “Read, Discuss, Decide”. They need to: - Read – what is displayed on the screen (Use the screen shot on this slide to “Troubleshoot”)
- Discuss – what is displayed so everyone know what is going on
- Decide – what is the correct action to take (“Cancel procedure” or , “Issue Corrected, Resume Procedure”)

38. Troubleshooting Fluid Loss Detected Alarms*
User actions for fluid loss alarms:
Ensure sheath is positioned beyond the internal cervical os to ensure proper fluid flow
If there is cervical leakage, consider adding second tenaculum
If fluid loss alarms continue
Consider procedure cancellation
Call Rep
On a fluid loss, if you verified all that is on the screen, here are some helpful user actions for fluid loss alarms. If these do not help, abort the case or call the Rep.
* Refer to User’s Manual for all troubleshooting information when using the Genesys HTA™ System

39. Conclusion It is as easy as…. Read, discuss, decide
Read the slide. Emphasis on “Ease of use”.
Genesys HTA, Genesys HTA Procerva, HTA, HTA Procerva and Uterine Health Institute are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners.

40. Disclaimers
Refer to Genesys HTA™ System Installation and Operator’s Manual provided with product for complete instructions for use.
INDICATIONS: The Genesys HTA System is a hysteroscopic thermal 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. CONTRAINDICATIONS: The Genesys HTA System is contraindicated for use in a patient: who is pregnant or wants to be pregnant in the future, as pregnancy after ablation can be dangerous to both mother and fetus; who has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia; who has active pelvic inflammatory disease or pyosalpinx; hydrosalpinx; in whom a tight cervical seal cannot be established and maintained around the procedure sheath; who has any anatomical or pathologic condition in which weakness of the myometrium could exist, such as, prior classic cesarean section or transmural myomectomy; who has an intrauterine device in place; or who has active genital or urinary tract infection, e.g., cervicitis, endometritis, vaginitis, cystitis, etc., at the time of treatment. POTENTIAL ADVERSE EFFECTS that may occur include: pain, cramping, nausea, vomiting, bleeding, infection, laceration, Endometritis, thermal injury to adjacent tissue including cervix, vagina, vulva, and/or perineum; heated saline escaping from the device system into the vascular spaces; hemorrhage; perforation of uterus; complications with pregnancy (Note: pregnancy following ablation is dangerous to both the mother and the fetus); risks associated with hysteroscopy, complications leading to serious injury and death, post-ablation tubal sterilization syndrome, and delayed diagnosis of cancer of the endometrium.
WARNINGS: NOTE: Failure to follow any instructions or to heed any Warnings or Precautions could result in serious patient injury.
CAUTION: Federal Law restricts this device to sale by or on the order of a physician. The physician using the device must be trained in diagnostic hysteroscopy.