Description

The SHARP AVF NEEDLE, crafted by Perfect Medical Industry (VN) Co., Ltd., is a specialized single-use needle set designed for effective vascular access in hemodialysis treatments. This essential medical device is intended for the temporary cannulation of arteriovenous (AV) fistulas, providing a reliable connection between an artery and a vein for extracorporeal blood treatment.

Key Features

• Needle Design: The needle features an ultra-sharp, siliconized 3-bevel tip that ensures smooth and easy cannulation. Its ultra-thin wall construction optimizes blood flow, enhancing the efficiency of the dialysis process.

• Grip and Identification: The needle is equipped with textured, color-coded wings that can be either turnable or fixed, offering a secure grip and easy gauge identification. Additional components include a color-coded occlusion clamp and a tapered luer for comprehensive functionality.

• Tubing and Withdrawal: Soft, kink-resistant tubing and a beveled back eye facilitate efficient blood withdrawal, while various safety features such as anti-backflow systems and retraction mechanisms enhance secure handling.

Safety and Material Specifications

• Materials: Constructed from medical-grade stainless steel (304 or 316L), the needle boasts high corrosion resistance. It is latex-free and not made with BPA or DEHP, ensuring compatibility with a wide range of patients.

• Coating and Sterilization: The needle's biocompatible materials include a silicone coating to reduce friction. It is sterilized using gamma or ethylene oxide methods, remaining non-pyrogenic and safe for single use only.

Technical Specifications

• Gauge Sizes: Available in 14G, 15G, 16G, and 17G.
• Needle Lengths: Ranges from 20 mm to 32 mm.
• Tube Lengths: Options of 150 mm and 300 mm.

Manufacturing Excellence

Manufactured with precision techniques such as laser cutting, grinding, electropolishing, and ultrasonic cleaning, the SHARP AVF NEEDLE achieves a smooth, burr-free, and sterile finish. Rigorous quality control inspections, including magnified inspection of needle tips and holes, ensure adherence to high standards.

Compliance and Testing

The product complies with several international standards, including ISO 9001:2015, ISO 13485, and others related to biocompatibility and needle quality. Performance testing covers flow rate, leakage, particulate contamination, and tensile strength, alongside comprehensive biocompatibility assessments.

Usage Instructions

Healthcare professionals are advised to inspect the packaging for damage before use, ensuring it is intact. The needle should be connected to the blood vessel and hemodialysis tubing set according to clinical protocols and discarded safely after single use.

Storage Recommendations

Store the SHARP AVF NEEDLE in a dry, cool place, away from sunlight and extreme temperatures. Ensure sterility protectors remain intact to maintain product safety and efficacy.