Description

The NEEDLES BIOPSY MAGNUM system, crafted by Bard (BD), is an advanced solution for medical professionals seeking precision in core biopsy procedures. This system is specifically designed for obtaining tissue samples from various soft tissues, including the liver, kidney, prostate, breast, spleen, and lymph nodes. It comprises the Magnum™ Reusable Core Biopsy Instrument and its compatible disposable biopsy needles, engineered for accuracy and ease of use.

Magnum™ Reusable Core Biopsy Instrument

This high-power, lightweight device features an ergonomic design with a one-handed cocking mechanism, enhancing handling and control. The instrument offers adjustable penetration depths of 15 mm and 22 mm, coupled with a high velocity throw, ensuring consistent, high-quality tissue samples. A built-in safety mechanism further enhances its reliability.

Sterilization and Maintenance

The instrument is designed for repeated use, requiring sterilization through autoclaving or ethylene oxide. Proper cleaning involves mild non-detergent soap and thorough drying, with the use of a medical grade lubricant compatible with the chosen sterilization method. Regular inspection for any signs of damage is recommended to maintain optimal performance.

Disposable Core Biopsy Needles

These needles are available in various gauge sizes (12G to 20G) and lengths (10 cm to 30 cm), providing versatility to suit different procedural needs. Key features include color-coded depth stops, echogenic needle tips for precise ultrasound guidance, and centimeter markings for accurate depth placement. The smooth surface and easy loading mechanism facilitate seamless integration with the biopsy instrument.

Additional Features

Some models include a user-friendly spacer handle for precise placement and manual insertion. Typically packaged with 10 needles per case, these needles are designed for single use, ensuring sterility and performance.

Compatible Accessories

The system is complemented by TruGuide™ Disposable Coaxial Biopsy Needles and TruLok™ Disposable Coaxial Introducers, available in various sizes and sold separately. These accessories enhance the system’s versatility and application in different clinical settings.

Intended Use and Precautions

The NEEDLES BIOPSY MAGNUM system is intended for use under imaging guidance, such as ultrasound or CT, and is not suitable for bone biopsies. It is crucial for users to be aware of specific precautions, including contraindications related to bleeding abnormalities and anticoagulant therapy. The device is regulated under federal law, restricting its sale to or on the order of a physician.

Operational Guidance

Detailed operational instructions, including energizing the instrument, selecting throw depth, and needle insertion, are provided to ensure effective use. The system is designed to allow multiple biopsies in the same area, maintaining a clear path for accurate sampling.

Maintenance Instructions

Comprehensive guidelines for troubleshooting, cleaning, lubrication, and sterilization are included, supporting long-term functionality and reliability of the Magnum™ Biopsy System.