Description

The Intervention Ureteric Catheter is a specialized, single-use medical device designed for advanced endoscopic urological procedures. Its primary applications include kidney stone management and facilitating various therapeutic interventions within the urinary tract. This catheter is intended for use by trained healthcare professionals in hospital settings, ensuring precise and effective treatment outcomes.

Key Features

• Steerable Design: The catheter features a steerable shaft with dual lumens, providing both irrigation and vacuum functionalities. This design enhances maneuverability and control during procedures.

• Hydrophilic Coating: The distal length of the catheter is hydrophilic coated, measuring 43 cm, which aids in smooth navigation through the urinary tract.

• Working Specifications: With a working length of 70 cm and an outer diameter of 11.9 Fr (3.97 mm), it is equipped with a working channel inner diameter of 7 Fr (2.33 mm).

• Articulation Capability: The catheter offers an articulation range of 250° both upwards and downwards, allowing for precise positioning.

• Integrated Technology: The distal tip includes openings for irrigation and the working channel, a digital image sensor, and dual light sources for enhanced visibility.

Compatibility and Accessories

The catheter is compatible with standard 12/14 Fr ureteral access sheaths, stone removal baskets, and laser fibers. It comes with essential accessories such as an introducer, laser bridge, trigger tie, 3-way stopcock, vacuum port cap, and a removable stone collector.

Safety and Compliance

• Sterilization: Supplied sterile via ethylene oxide sterilization and intended for single use only.

• Material Composition: Made from 100% silicone and/or hydrogel, ensuring it is latex-free.

• Electromagnetic Compatibility: Compliant with relevant IEC standards, ensuring safe operation in medical environments.

Usage Guidelines

Healthcare professionals are advised to use aseptic techniques during insertion, maintenance, and removal to minimize risks such as trauma and infection. Proper documentation and adherence to clinical guidelines are essential for optimal outcomes.

Contraindications and Precautions

The catheter should not be used in patients with untreated urinary tract infections, coagulation disorders, severe cardiopulmonary insufficiency, or known allergies to the device materials. Potential adverse events include perforation, bleeding, infection, and ureteral avulsion.

Storage and Handling

Store the device away from sunlight, within safe humidity levels (15–90%), and appropriate atmospheric pressure (500–1060 hPa). Ensure packaging integrity before use and follow proper waste management protocols for disposal.

This comprehensive design and feature set make the Intervention Ureteric Catheter a vital tool for effective urological interventions, enhancing procedural success and patient care.