Single-Use Ureteral Access Sheath

Intended purpose

The device is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

Intended user and use environment

For trained medical personnel used in Professional Healthcare Facility.

Clinical Benefits
–Simplified and rapid entry and re-entry into theureter and collecting system;
–Prevention of increased intrarenal pressure;
–prevents pyelovenous reflux of large amounts of perfusion during surgery;
–Improve vision;
–Increases irrigation outflow ;
–Improve stone-free rate.

Contraindications
Contraindications to the use of the single-use ureteral access sheath are as follows:
–Patients who have contraindications for retrograde urological procedures.
–Patients who are unable to tolerate urological endoscopic procedures.
–Patients who are contraindicated for antegrade urologic procedures include those with blood clotting anomalies due to coagulopathies or pharmacological anticoagulation.
–Patients who have tight strictures that would limit the use of the device.
–Patients who have large obstructing distal ureteral calculi.
–Patients who are allergic to the product material.
–Contraindicated in patients with long ureteral strictures, severe atresia, and severe periureteral fibrosis.
–Contraindicated in cases where the product is incompatible with medical devices.

Adverse Events
Potential adverse events associated with the use of the transurethral access device include, but are not limited to:
–Mucosal irritation, inflammation and edema
–Uretheral strictures
–Acute bleeding or hemorrhage
–Urethral, bladder, or ureteral perforation
–Other injury to the urinary tract

Warnings:
–Do not attempt to operate this product without reading the entire Instruction Manual, as any careless operation may pose a surgical risk.
–Please strictly follow the warnings and precautions outlined in this Instruction Manual, as failure to do so may result in severe consequences for the patient.
–Do not use this product for purposes other than its intended use.
–For detailed warnings regarding the device please refer to the Instruction for use.