DESCRIPTION:
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.

SPECIFICATIONS:
• 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.

INSTRUCTION FOR USE:
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