Description

TEMNO Biopsy Systems, developed by CAREFUSION, offer a comprehensive range of core needle biopsy devices designed for precise tissue sampling from various soft tissues, including the breast, kidney, liver, lung, prostate, spleen, lymph nodes, and thyroid. These single-use, sterile devices are intended for use by trained physicians under imaging guidance, ensuring accurate and reliable results.

Key Features

• Versatile Models: The TEMNO Biopsy Systems include several models such as the Evolution, Elite, and Adjustable Coaxial TEMNO (ACT) devices, each tailored to meet specific clinical needs. These models provide options for different needle sizes and lengths, enhancing adaptability to various biopsy requirements.

• Ergonomic Design: Each device features a lightweight, compact design that allows for one-handed operation. The ergonomic control is further enhanced by tactile plunger enhancements and soft finger grips, providing comfort and precision during use.

• Advanced Needle Technology: The devices are equipped with a four-bevel, super-sharp tip for easy penetration and reduced tissue trauma. Echogenic markings on the cannula and stylet, along with centimeter depth markings, ensure precise positioning and accurate needle placement.

• Coaxial Introducer Needles: Available with or without coaxial introducer needles, these devices allow for multiple sampling from a single puncture. The introducer needles feature a positive-locking skin stop, trocar-point stylet, and blunt-ended cannula, all designed to enhance procedural efficiency.

Model-Specific Features

• TEMNO Elite Biopsy System: This model includes Total Core Biopsy Technology for larger sample sizes, adjustable throw lengths, and color-coded plungers for easy gauge identification. Unique features such as the Sample Assist for hands-free core retrieval and indicators for fire readiness and penetration depth provide added convenience.

• Adjustable Sample Notch: Depending on the model, the sample notch can be fixed or adjustable, allowing for precise sampling. The notch can be positioned within the lesion before firing, ensuring targeted tissue collection.

Materials and Safety

Constructed from medical-grade stainless steel and ergonomic plastic components, the TEMNO Biopsy Systems are sterilized using ethylene oxide. These devices are for prescription use only and are not intended for re-sterilization. They are contraindicated in patients with bleeding disorders or those on anticoagulant therapy, with potential complications including hematoma, pain, bleeding, infection, and air embolism.

Packaging and Instructions

The devices are supplied in boxes of 5 or 10, with packaging clearly indicating the use-by date, lot number, and date of manufacture. Instructions for use are available electronically or in print, ensuring that healthcare providers have access to essential operational guidance.