Description

The K-ZERO Needleless Connector is an advanced medical device designed to enhance the safety and efficiency of vascular access management. Its neutral displacement mechanism is engineered to prevent blood reflux during syringe connection and disconnection, significantly reducing the risk of catheter occlusion and catheter-related bloodstream infections.

Key Features

• Microbial Barrier: The connector automatically closes after disconnection, forming a tight seal that effectively prevents microbial ingress. The smooth, gap-free surface ensures easy disinfection, enhancing patient safety.

• Innovative Septum Design: The split and concave septum design provides a secure closure after activation, minimizing the risk of syringe tip slip-off and contamination.

• Straight Fluid Path: With zero dead space and minimal residual volume, the connector allows for effective flushing, lowering infection risks.

• Bi-directional Flow Control: Equipped with a pressure-activated anti-reflux diaphragm, it offers bidirectional flow control to prevent unintentional backward flow and blood reflux.

Ease of Use

The K-ZERO Connector is designed for seamless integration with existing medical equipment. It requires no clamping technique and is compatible with ISO standard luer lock connectors, making it suitable for use with syringes, IV extension sets, and more. Its compatibility extends to blood and lipid infusates and is safe for use in MRI environments, as it contains no metallic components.

Material and Safety

Constructed from high-quality materials such as silicone, MABS, copolyester, and polycarbonate, the connector is not made with natural rubber latex or DEHP, reducing allergy risks. It is sterile, with a nonpyrogenic fluid path, and intended for single use only.

Performance Specifications

• Priming Volume: 0.07 mL
• Flow Rate: 125 mL/min
• Pressure Rating: Up to 325 PSI for power injection

The device is designed for up to 7 days of use or 200–300 activations, aligning with hospital protocols or CDC guidelines. It can be easily disinfected with a 3-second scrub using 70% isopropyl alcohol.

Compliance and Testing

The K-ZERO Needleless Connector has undergone rigorous testing and validation, including microbial ingress protection, hemolysis prevention, and biocompatibility. It is FDA 510(k) cleared and classified as a Class II medical device, ensuring adherence to high medical standards.

Handling Instructions

Proper handling requires aseptic techniques during connection and storage in a dry, controlled environment away from sunlight. The connector is not intended for use with sharp needles or beyond the specified duration and number of activations.

The K-ZERO Needleless Connector represents a reliable solution for healthcare providers, offering robust protection against infections and enhancing the overall quality of patient care.