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The Asurys™ Fluid Management System is intended for use in conjunction with an endoscope to provide irrigation and distention within endourological procedures.

The Asurys Fluid Management System (FMS) is a multi-functional system for use in a healthcare facility. This device is used during endourological procedures to manage fluid delivery to the patient. This system is comprised of an electromechanical console (capital unit) and a single-use sterile cassette and scope line (also known as Single-Use Device or SUD). The cassette works with the capital unit to apply pressure to the irrigation fluid being used in endourological procedures. Irrigation fluid from a standard source is pumped through a disposable inflow tubing set. The fluid is then delivered through a separate urological endoscope and into the patient's urinary tract. The subject device is compatible with the following fluids: Saline (0.9%), Sterile water, Glycine (1.5%), Mannitol (5%), Sorbitol (3%), Mannitol/Sorbitol (0.54%/2.7%), Glucose (5%). The Asurys FMS supports irrigation across a range of urological procedures, including Ureteroscopy (URS), Percutaneous Nephrolithotomy (PCNL), cystoscopy, and Benign Prostatic Hyperplasia (BPH) procedures. For each procedure type, the physician can utilize the system in Standalone mode, compatible with various urological endoscopes. In this mode, the physician sets a desired pump pressure which is maintained by the Asurys FMS through its software-controlled peristaltic pump. When used with a LithoVue Elite Single-Use Digital Flexible Ureteroscope, the physician can use the Asurys FMS in LithoVue Elite (LVE) mode for URS and PCNL procedures. In this mode, the LithoVue Elite's StoneSmart Connect console is connected to the Asurys FMS console, allowing the physician to use the LithoVue Elite scope buttons to control the irrigation settings and also to initiate an on-demand fluid flush (low, medium, and high flush options are available). When used with a LithoVue Elite device which has intraluminal pressure (ILP) monitoring, the physician can also regulate fluid flow based on ILP in addition to the pump pressure setting. The physician sets ILP flow limiter and flush limiter settings so that the Asurys FMS limits fluid flow to reduce the occurrence of higher-than-desired ILP. In addition, ClariSee (software feature) automated flow compensation is supported, which enables consistent fluid flow to be maintained while the working channel of the scope is occupied by instrumentation. Automated flow compensation generates additional pressure (setpoint +150mmHg pump pressure) to maintain the fluid flow when there is more resistance to fluid flow due to the working channel being occupied with surgical tools. This feature is only possible in LVE Mode. If pressure monitoring data is not available from LithoVue Elite device, then Asurys FMS can operate in LVE Lite mode, which allows use of the LithoVue Elite scope buttons to control the irrigation settings and also to initiate an on-demand fluid flush (low and medium flush options available) but without the ILP flow/flush limiters or ClariSee automated flow compensation.

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