Instructions for Use

20 Pages

INSTRUCTIONS FOR USE GYNECARE THERMACHOICE* III Uterine Balloon Therapy System  Thermal Balloon Ablation Silicone Catheter and Syringe (Single-Use) Read all directions, precautions and warnings prior to use. This instructions for use provides directions for using the GYNECARE THERMACHOICE* III 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 III UBT System is a software-controlled device designed to ablate uterine tissue by thermal energy. The system is comprised of a single-use silicone balloon catheter, a reusable controller, umbilical cable, and power cord. The GYNECARE THERMACHOICE III Catheter is designed for use only with the GYNECARE THERMACHOICE III UBT System Controller. The silicone balloon catheter is 1) connected to the controller, 2) inserted through the cervix into the uterus, 3) filled with sterile, injectable fluid (5% dextrose in water- D5W) carefully stabilizing the pressure to 160-180 mmHg pressure, and 4) activated to thermally ablate endometrial tissue by maintaining a temperature of approximately 87°C (188°F) for 8 minutes.  GYNECARE THERMACHOICE III Single-use Silicone Balloon Catheter with Fluid Circulation and Umbilical Cable  INDICATIONS The GYNECARE THERMACHOICE III UBT System is 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.  CONTRAINDICATIONS The device is contraindicated for use in • • •  A patient who is pregnant or who wants to become pregnant in the future. Pregnancies following ablation can be dangerous for both mother and fetus. A patient with known or suspected endometrial carcinoma (uterine cancer) or premalignant change of the endometrium, such as unresolved adenomatous hyperplasia. A patient with any anatomic condition (e.g., history of previous classical cesarean sections or transmural myomectomy) or pathologic condition (e.g., chronic immunosuppressive therapy) that could lead to weakening of the myometrium.  389605.R06.indd 1  10/12/07 4:09:18 PM
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File Name: Ethicon Womens Health & Urology - THERMACHOICE III Instructions for Use.pdf

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