Description

The TEMNO Biopsy Needles by CareFusion are expertly crafted for precise soft tissue sampling in various clinical settings. These single-use, sterile devices are designed to obtain core biopsies from tissues such as the breast, kidney, liver, lung, prostate, spleen, lymph nodes, and thyroid, while explicitly not intended for bone biopsies.

Versatile Design

The product line offers a comprehensive range of models and system variants, each tailored with specific gauge sizes and lengths to accommodate diverse biopsy procedures. The available gauges range from 12G to 22G, and lengths span from 6 cm to 20 cm, providing flexibility to meet specific clinical needs.

Precision Engineering

Each needle features a four-bevel, super-sharp or standard bevel tip, ensuring quick penetration with minimal tissue trauma. The echogenic markings and centimeter depth indicators on the cannula and stylet enhance visibility under ultrasound and CT imaging, allowing for accurate placement.

Ergonomic Features

The compact, lightweight construction of these needles includes an ergonomically designed plunger for one-handed operation, reducing tissue shear and enhancing user comfort. Many models come with or without coaxial introducer needles, facilitating multiple sample collections from a single puncture with minimal repositioning.

Advanced Sampling Options

TEMNO Biopsy Needles offer variable sample notch sizes—10 mm, 20 mm, or adjustable between 9–19 mm—providing controlled and precise tissue sampling. Certain models also feature a fire-ready indicator and the Sample Assist™ function for efficient core retrieval.

Introducer Needle Specifications

The introducer needles are equipped with a positive-locking skin stop, trocar-point stylet, and a blunt-ended cannula to minimize tissue damage. They are typically one gauge size larger than the core needle, except for specific sizes, and include a clear luer lock hub for secure connections.

Safety and Identification

These devices are sterilized using ethylene oxide and are clearly labeled with a use-by date, lot number, and date of manufacture. Color-coded plungers and introducer needles allow for easy gauge identification, enhancing operational efficiency.

Model Variants

• Temno Evolution: Features notch sizes of 10 mm or 20 mm, available in sizes 14G to 20G.
• Adjustable Coaxial Temno (A.C.T.): Offers adjustable notch size and stylet repositioning.
• Original Temno: Provides a 20 mm sample notch with optional coaxial introducer.
• TEMNO Elite Biopsy System: Includes Total Core™ design and optional Sample Assist™ feature.

Indications and Usage

These needles are intended for use under imaging guidance and should be employed by or on the order of a physician. They are not recommended for patients with bleeding disorders or those on anticoagulant therapy. Potential complications include hematoma, hemorrhage, infection, and adjacent tissue injury.

For comprehensive usage instructions, refer to the provided Instructions for Use, detailing indications, contraindications, warnings, and operational guidelines.