Description

The SHARP AVF Needle is a specialized medical device designed for effective and safe vascular access during hemodialysis, hemofiltration, and hemodiafiltration. As a single-use, sterile needle, it is intended for use with arteriovenous (AV) fistulas, providing a reliable connection between blood line tubing and blood vessels. This ensures the aseptic removal and return of blood to and from an extracorporeal circuit.

Key Features

• Ultra-Sharp Needle: The needle is siliconized with a 3-bevel design, allowing for smooth cannulation and minimal trauma to the vessel. Its ultra-thin wall enhances blood flow, while the pointed tip facilitates easy penetration, making it suitable for new AV fistulas or patients with tougher skin.

• Ergonomic Design: Equipped with ergonomic wings that are either fixed or rotatable, the needle offers a secure grip and easy handling. The wings and occlusion clamp are color-coded for easy identification.

• Safety Mechanisms: Includes a Luer-lock connector compliant with ISO 80369-7 and a protective shield with a manual activation mechanism to prevent accidental needlesticks. A tip protector further enhances safety.

• High Performance: Features such as high laminar blood flow, siliconized lumen to reduce friction, and an anti-backflow system contribute to its superior performance. Available with or without a backeye, recommended for arterial use.

Configurations

The SHARP AVF Needle is available in various configurations to meet diverse clinical needs:

• Gauge Sizes: 14G, 15G, 16G, 17G
• Needle Lengths: 15 mm, 20 mm, 25 mm, 30 mm, 32 mm
• Tube Lengths: 150 mm, 300 mm
• Wing Types: Fixed or rotatable
• Set Types: Arterial, venous, or combined sets

Material and Sterilization

Manufactured from biocompatible materials, the needle is latex-free, BPA-free, and DEHP-free. It is sterilized using gamma radiation or ETO, with sterility maintained for up to three years.

Certifications

The SHARP AVF Needle is CE certified and complies with several ISO standards, including ISO 13485:2016 for quality management and ISO 10993 for biocompatibility. It also meets the requirements of ISO/FDIS 9626:2016 for needle tubing.

Instructions for Use

Healthcare professionals are advised to insert the needle at a 25° angle with the bevel up, ensuring the skin is taut during insertion. Proper technique includes matching the needle gauge to the desired blood flow rate and securing the needle once successful entry is indicated by blood flashback.

Intended Audience

This device is intended for use by physicians or under physician supervision, with a strict adherence to aseptic techniques. It is not approved for use by nursing women, pregnant women, or children.

Maintenance

The SHARP AVF Needle is designed for single use only. Users are recommended to perform visual inspections for blood leaks and ensure proper fixation during use.