Description

The TEMNO NEEDLE BIOPSY device is a specialized tool designed for healthcare professionals to obtain core tissue samples from various soft tissues, including organs such as the breast, kidney, liver, and more. Manufactured by Cardinal Health, Merit Medical Systems, Inc., and CareFusion, this device is intended for use under imaging guidance, such as ultrasound or CT, providing precision and reliability in biopsy procedures.

Key Features

• Semiautomated Design: The device features a side-cutting core biopsy needle system, enhancing ease of use and effectiveness in soft tissue biopsy procedures.
• Imaging Compatibility: Equipped with echogenic markings on the cannula and stylet, it offers enhanced visibility under ultrasound, ensuring accurate placement.
• Ergonomic Design: The compact and lightweight body allows for one-handed operation, with a tactile-enhanced plunger for ergonomic control.

Performance

• Adjustable Sample Notch: Available in variable sizes, the sample notch and throw length can be adjusted to meet specific procedural needs.
• Sharp Tip Design: The super-sharp bevel tip facilitates easy penetration with minimal tissue trauma, improving tracking and precision.
• Coaxial Introducer: Options include standard or valved coaxial introducer needles, enhancing accurate placement.

Additional Features

• Fire Ready Indicator: Select models include indicators for readiness, along with the Sample Assist™ feature for sample retrieval.
• Color Coding: Needle gauge sizes are color-coded for easy identification, available in gauges 12G to 20G and lengths ranging from 6 cm to 20 cm.

Safety and Handling

• Single-Use Sterile Packaging: Each device is ethylene oxide sterilized and intended for single use, supplied typically in cases of 5 or 10.
• Aseptic Technique: Designed for use with aseptic technique, ensuring safety and reducing the risk of complications.
• Contraindications: Not suitable for patients with bleeding disorders or those on anticoagulant therapy.

Regulatory Information

• CE Marking: The device carries CE 2797 marking and is restricted to sale by or on the order of a physician.
• Instructions for Use: Available electronically or in print, providing comprehensive guidance for healthcare providers.

The TEMNO NEEDLE BIOPSY device stands as a trusted instrument in medical diagnostics, offering precise, reliable performance tailored to the needs of trained physicians in various clinical settings.