Genesys HTA System User’s Manual

The Genesys HTA™ System is a software-controlled hysteroscopic thermal endometrial ablation device that consists of an operational unit (control unit, pedestal and IV pole) and a sterile procedure set. Additionally, an HTA hysteroscope adapter (scope adapter) will be needed.

The Genesys HTA ProCerva™ Procedure Set is disposable and consists of a procedure sheath, a cassette, and a drainage bag. The Genesys HTA ProCerva Procedure Sets are packaged in a box of five.

Additional components and accessories required for use with the Genesys HTA System include: 3 liters (L) 0.9% normal saline bags, a standard ≤ 3 mm diameter hysteroscope, a cervical sealing tenaculum, and a vaginal speculum.

The Genesys HTA System is designed to ablate the endometrial lining of the uterus by heating saline to a temperature of 90°C through a heating element located in the disposable cassette. The heated fluid is re-circulated through the uterine cavity for a period of 10 minutes. Sensors in the Genesys HTA System monitor the safe and effective delivery of the treatment therapy.

Prior to using the Genesys HTA™ System, carefully read this entire User’s Manual to become familiar with the Genesys HTA System’s features and controls. This manual contains information about the proper procedures for inspecting, preparing, and operating the Genesys HTA System.

Failure to thoroughly understand and follow these instructions may result in serious injury to the patient and/or the user; and/or may result in damage to, or malfunction of, this equipment.

Follow all instructions, cautions, and warnings provided with all products and equipment to be used in conjunction with the Genesys HTA System to avoid any possible hazard from equipment incompatibility.

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