Pre-Filled Artificial Urinary Sphincter

The Artificial Urinary Sphincter ZSI 375 PF is a long-term implantable medical device, designed to correct urinary incontinence
secondary to an intrinsic urinary sphincter deficiency. This Artificial Sphincter is composed of a Cuff connected by kink-resistant
tubing to a Pump. The Cuff is placed around the urethra and a Pump is placed in the scrotum.

• Ready to be implanted, no preparation.
• Pre-connected.
• Pre-filled with saline solution.
• Adjustable Cuff from 4 to 6 cm.
• Cuff closure with buttons.
• Adjustable pressure from 0 cm H2O to over 120 cm H2O. ZSI 375 PF is provided with a standard issued pressure of 90 cm H2O
(90 +/- 5 cm H2O). The standard issued pressure can be increased or decreased during implantation and/or during sphincter
lifetime, injecting or removing saline solution from the Pressure Regulating Balloon PRB/Compensation Pouch.
• Pressure can be controlled with pressure sensor at any time.
• MTBF (Mean Time Before Failure): 10 years.
• MCBF (Mean Cycle Before Failure): 30 000 cycles.
• Provided with two Huber needles.
The Pressure Sensor to control the issued pressure is not included in the ZSI 375 PF box.

The patient presses and releases the bulb button of the Pump to open the Cuff and urinate.
The closure of the Cuff is automatic after 2 to 3 minutes