Description
The SHARP AVF Needle is a specialized medical device designed for effective and reliable vascular access during hemodialysis treatment. Engineered for single use, this sterile needle is crafted to provide seamless vein puncture, facilitating efficient blood flow to and from a patient's arteriovenous fistula.
Key Features
-
Advanced Needle Design: The needle features an ultra-sharp, siliconized 3-bevel design, ensuring smooth cannulation with minimal insertion pain. Its ultra-thin wall and optimal bevel shape enhance blood flow, while the sharp pointed tip allows for easy entry into the fistula.
-
Silicone Coating: A smooth silicone coating reduces friction and tissue trauma, promoting patient comfort.
-
Butterfly Wings: The needle is equipped with color-coded, textured butterfly wings that are either fixed or rotatable, providing secure and comfortable handling. The rotating hub and wings allow for precise adjustment of blood flow, pressure, and needle angle.
-
Kink-Resistant Tubing: Clear tubing with a smooth occlusion clamp ensures reliable performance, while features like a back eye hole or ellipse back hole optimize blood flow and ease of use.
Safety and Protection
-
Protective Shield: After use, a locking protective shield with a slide-forward mechanism covers the cannula, significantly reducing the risk of accidental needlestick injuries. This patented safety device is clinician-activated, enhancing overall safety.
-
Thromboresistant Design: Constructed from non-toxic, biocompatible materials, the needle is latex-free and free from BPA and DEHP, ensuring compatibility with a wide range of patients.
Compliance and Quality
-
Material Composition: The needle is made from medical-grade stainless steel, with other components crafted from biocompatible, non-toxic materials.
-
Sterilization: Gamma sterilized to a high assurance level, the needle complies with numerous international standards, including ISO 10993, ISO 9626, and ISO 7864, among others.
-
Quality Standards: Adheres to ISO 9001:2015 and ISO 13485 quality standards, with rigorous non-clinical testing for flow rate, leakage, and tensile strength.
Specifications
-
Needle Gauge Options: Available in various gauges (14G, 15G, 16G, 17G) and lengths, with tube lengths tailored to specific clinical needs.
-
Packaging: Offered in different configurations, including arterial, venous, or combined sets, with options for fixed and rotating wing types.
Usage and Handling
-
Single-Use Design: Intended for single use only, the needle should be disposed of properly after use. Activation of the protective shield post-use is crucial to prevent needlestick injuries.
-
Packaging: Each needle is provided in sterile packaging, with options for custom packaging to meet specific requirements.
The SHARP AVF Needle represents a commitment to quality and safety, providing healthcare professionals with a reliable tool for effective hemodialysis treatment.
