Instructions for Use Incorporating Operator's Manual
Field Safety Notice: IFU Update
TCU Step-by-Step Set Up Guide
ExEm® Foam Kit
Instructions for Use
Instructions for Use
Instructions for Use
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ExEm Foam Kit®
Q: When will I be going home?
A: You will be going home approximately 1 hour after your procedure.
You may want to have someone accompany you home in case you are not up to driving immediately after a procedure.
Q: How will I feel after the procedure?
A:If you have any questions or concerns, speak with your doctor or the nurses looking after you.
Do not use tampons, use sanitary pads for two weeks after the procedure. Some women experience very little bleeding or none at all. Others may experience bleeding similar to menstruation. Some women may have a watery vaginal discharge as well. As a result of the ablation, most women will experience intermittent discharge or bleeding for up to 6 weeks after the procedure as the lining is sloughed off and healing.
You may shower the next day after the procedure, but you should avoid putting anything in the vagina for two weeks after the procedure. Please avoid intercourse, tub baths, swimming and douching for two weeks.
Q: How much pain will I feel?
A: Pain and/or discomfort are usually minimal, similar to menstrual cramps. It should be controlled with the prescription given to you by your doctor when you are discharged home. Tylenol, Ibuprofen and Tylenol Extra Strength are usually enough for mild pain.
Q: What about activity?
A: You may go back to work when you feel up to it. If it is the next day, make sure you are not standing for long periods or lifting heavy objects.
Q: What about eating?
A: You may resume your normal diet.
Q: What should I be concerned about and report?
A: Persistent fever, chills, sweating
Any difficulty breathing or shortness of breath
Persistent and increasing abdominal pain
Persistent vomiting and inability to drink fluids for greater than four hours
Not being able to urinate within the first 12 hours after surgery
Vaginal bleeding that is more than a normal menstrual period
Q: When Will My Follow Up Appointments Be?
Q: What Should I Bring To My Follow Up Appointment?
A: You will need to bring your menstrual calendar history and ensure that it is up to date
If you have any concerns, contact your doctor or go to your nearest Emergency Department
Healthcare Professionals FAQs
Q: Can any patient suffering from menorrhagia be treated with Thermablate EAS?
A: No. Like all other ablation devices, patients should be assessed to determine suitability for a global ablation procedure. Key assessments include:
- Normal Papanicolaou smear in accordance with clinical practice guidelines
- Normal endometrial biopsy (within past 6 months)
- Normal size and shape intrauterine cavity (as determined by hysteroscopy or ultrasound)
- Fertility is not required
- No previous ablation procedure
Q: What size uterus can be treated?
A: A uterus with a sounding length of 8cm – 12cm (external os to fundus) may be treated by Thermablate EAS.
Q: Is pre-treatment of the endometrium required?
A: It is recommended that patients take oral contraceptives for 3 weeks up to the date of treatment.
Q: What safety measures are advised when performing an ablation with Thermablate?
A: It is recommended that physicians perform a hysteroscopy prior to the treatment to check for possible uterine perforations done during dilation, sounding, or curettage (if performed), or to use ultrasonic surveillance during the treatment to check for correct balloon position inside the uterus cavity.
Q: Is a General Anesthetic required?
A: Many Thermablate procedures have been done using local anesthesia only. Compared to other ablation devices, patients have reported less intra and post operative pain with Thermablate.
Q: Can the procedure by stopped once it has started, and if so, how?
A: Treatment with Thermablate may be terminated by pressing the Emergency Stop button or by turning the power switch off, then on again. This will terminate the procedure and withdraw the glycerine from the balloon.
Q: What type of symptoms can occur after endometrial ablation is complete, and how long will they last?
A: Following an ablation, the patient may experience pain and cramping which typically lasts for less than 12 hours. A serosanguinous discharge usually begins a few days post procedure, typically continuing for 1 – 2 weeks. Occasionally tissue fragments are sloughed off and may be noticed in the discharge.
Q: What kind of maintenance is required on the Treatment Control Unit?
A: Routine maintenance is NOT required on the Treatment Control Unit.
Q: How should the Treatment Control Unit be cleaned?
A: Following the procedure, the control unit should be wiped down with a cloth that has been impregnated with a hospital grade disinfectant. As the unit contains electronic components, always avoid soaking or the use of excess free liquid.