Description

The NEEDLE SPINAL SPROTTE is a specialized medical device designed to enhance the safety and efficacy of spinal anesthesia and lumbar puncture procedures. Known for its atraumatic design, this needle is crafted to minimize tissue damage, thereby reducing the risk of post-dural puncture headache (PDPH) and enhancing patient comfort.

Key Features

• Pencil-Point Tip Design: The ogive-shaped tip gently displaces tissue rather than cutting it, significantly lowering the risk of trauma to nerves, dura, and blood vessels.
• Lateral Eye with Smooth Edges: Ensures unobstructed cerebrospinal fluid (CSF) flow and optimal anesthetic distribution, even in challenging conditions.
• High-Quality Construction: Made from stainless steel, providing durability and resistance to breakage, with a smooth surface for easy insertion and reliable CSF backflow.

Design and Usability

The NEEDLE SPINAL SPROTTE features an ergonomic hub design, available with or without an integrated magnifying glass, to enhance visualization of CSF or blood reflux. The hubs are color-coded for easy identification of needle gauge, and select models include graduated markings for precise depth control.

Size and Compatibility

Available in a wide range of sizes, this needle offers multiple gauges and lengths to accommodate various patient needs, including specialized versions for pediatric and obese patients. It is compatible with standard Luer or NRFit® connectors, adhering to ISO 80369-6 standards for enhanced safety.

Introducer and Sterility

Each needle size has a compatible introducer to protect the atraumatic tip and facilitate passage through tough tissues. The needles are single-use, ethylene oxide sterilized, and non-pyrogenic, ensuring high standards of biocompatibility and safety.

Packaging and Materials

Typically packaged in boxes of 10 or 25, the needle components are made from medical-grade materials, including stainless steel and polycarbonate. The device complies with international standards, offering a validated 5-year shelf life and being free from phthalates and natural rubber latex.

Indications and Contraindications

Intended for use in spinal anesthesia and diagnostic lumbar puncture, the NEEDLE SPINAL SPROTTE is suitable for adult, pediatric, and obese patients. It should only be used by qualified medical professionals and is contraindicated in cases such as patient refusal, coagulation disorders, and infection.

Storage and Usage Guidelines

The needle should be stored at temperatures between +10°C to +30°C, in a dry environment away from sunlight. It must not be reused or resterilized and is not suitable for MRI use or catheter insertion.

Manufacturer Information

Manufactured by PAJUNK® GmbH Medizintechnologie, this Class II medical device complies with all relevant standards and is supported by clinical studies and international guidelines, ensuring reliable performance and safety in medical settings.