Description

The Cleo 90 Infusion Set by Smiths Medical is a specialized subcutaneous infusion set designed for seamless medication delivery, such as insulin, through infusion pumps. This single-use, disposable device is crafted to enhance convenience and safety in both home and clinical settings.

Key Features

• All-in-One Design: The Cleo 90 combines the inserter, needle retractor, and sterile packaging into a single pre-assembled unit, streamlining the insertion process.
• One-Handed Insertion: Its intuitive design allows for quick, one-handed insertion with a single motion, making it user-friendly.
• Needle Retraction: Features automatic needle retraction post-insertion, minimizing the risk of accidental needlestick injuries.
• Enclosed Needle System: The needle and cannula are enclosed, reducing the need for direct contact and enhancing safety.

Flexible Tubing Connection

The infusion set offers a 360° tubing connection, providing flexibility and freedom of movement. It includes a standard luer lock connection, ensuring compatibility with various infusion pumps, including the Sequel Twiist insulin pump.

Specifications

• Cannula Lengths: Available in 6 mm and 9 mm.
• Needle Gauge: 28 gauge for the inserter needle and 25 gauge for the cannula.
• Insertion Angle: 90 degrees.
• Tubing Lengths: Options of 24", 31", and 42".

Adhesive Dressing

The set includes a small, transparent, hypoallergenic, and water-resistant adhesive dressing. It features a patented release tab for easy removal and is designed to remain secure with minimal additional tape.

Usage Instructions

• Insertion: Firmly press until a click is heard, hold for 5 seconds, then remove the inserter.
• Tubing Connection: Follow pump user manual instructions, ensuring secure connection with an audible click.
• Disconnection: Easily managed by pinching connector arms and sliding open.

Important Warnings

Users are advised not to fill tubing with medication while connected to the body to prevent unintended bolus delivery. The device is not intended for intravenous infusion or for use with blood products.

Biocompatibility and Testing

All materials used are biocompatible, having undergone rigorous in-vitro functional and biocompatibility testing, including simulated clinical use evaluation.

Regulatory Information

The Cleo 90 Infusion Set is classified as a Class II medical device, adhering to stringent regulatory standards to ensure safety and efficacy.